Creation Date : 18/01/2018

LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives
TÜV NORD CERT GmbH 0044
*MD 1300 - Monitoring devices Full quality assurance Annex II
Langemarckstraße 20
45141 Essen - *MD 1301 - Monitoring devices of non-vital system Annex III
Germany physiological parameters EC type-examination Annex IV
- *MD 1302 - Monitoring devices of vital physiological EC verification Annex V
parameters Production quality Annex VI
*MD 1400 - Devices for radiation therapy and thermo assurance
therapy Product quality assurance
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
transfusion and dialysis assurance
- *MD 0101 - Non-active devices for anaesthesia, Product quality assurance
emergency and intensive care
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0201 - Non-active cardiovascular implants

- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1101 - Devices for extra-corporal circulation, system Annex III
infusion and haemopheresis EC type-examination Annex IV
- *MD 1102 - Respiratory devices, devices including EC verification Annex V
hyperbaric chambers for oxygen therapy, inhalation Production quality Annex VI
anaesthesia assurance
- *MD 1103 - Devices for stimulation or inhibition Product quality assurance
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

prostheses
- *MD 1109 - Active devices for patient positioning and
transport
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1111 - Software EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1201 - Imaging devices utilising ionizing system Annex III
radiation EC type-examination Annex IV
- *MD 1202 - Imaging devices utilising non-ionizing EC verification Annex V
radiation Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1112 - Medical gas supply systems and parts EC verification Annex IV
thereof EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal without medical devices according
origin, including Regulation 722/2012 (Directive to Commission Regulation (EU) No
2003/32/EC up to 28.08.2013) 722/2012
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including ethylene oxide gas
sterilisation (EOG), moist heat
sterilisation, radiation sterilisation
(gamma, x-ray, electron beam),
low temperature steam and
formaldehyde sterilisation, thermic
sterilisation with dry heat

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7008 - Medical devices utilising nanomaterials

*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
National Standards Authority of Ireland (NSAI) 0050
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
1 Swift Square, Northwood, Santry
Dublin 9 medical devices conformity (full quality Annex V
Ireland - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
- *MD 0102 - Non-active devices for injection, infusion, conformity (production
transfusion and dialysis quality assurance)

- *MD 0103 - Non-active orthopaedic and rehabilitation EC declaration of

devices conformity (product quality
assurance)
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0204 - Non-active soft tissue implants

*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
- *MD 1106 - Active dental devices
- *MD 1108 - Active rehabilitation devices and active

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

prostheses
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7006 - Medical devices in sterile condition

*MDS 7007 - Medical devices utilising micromechanics
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
IMQ ISTITUTO ITALIANO DEL MARCHIO DI 0051
*MD 0100 - General non-active, non-implantable EC declaration of Annex II exclusion medical devices class III
QUALITÀ S.P.A.
Via Quintiliano, 43 medical devices conformity (full quality Annex V
20138 - MILANO - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
Italy
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II exclusion medical devices class III
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II exclusion medical devices class III
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II exclusion medical devices class III
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II exclusion medical devices class III
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II exclusion medical devices class III
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II exclusion medical devices class III
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II exclusion medical devices class III
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II exclusion medical devices class III
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II exclusion medical devices class III
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II exclusion medical devices class III
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II exclusion medical devices class III
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II exclusion medical devices class III
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II exclusion medical devices class III
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1101 - Devices for extra-corporal circulation, EC verification Annex IV
infusion and haemopheresis EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1102 - Respiratory devices, devices including EC verification Annex IV
hyperbaric chambers for oxygen therapy, inhalation EC declaration of Annex II
anaesthesia conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1103 - Devices for stimulation or inhibition EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1104 - Active surgical devices EC verification Annex IV

EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1105 - Active ophthalmologic devices EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1106 - Active dental devices EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1107 - Active devices for disinfection and EC verification Annex IV
sterilisation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1108 - Active rehabilitation devices and active EC verification Annex IV
prostheses EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1109 - Active devices for patient positioning and EC verification Annex IV
transport EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC type-examination Annex III
- *MD 1201 - Imaging devices utilising ionizing EC verification Annex IV
radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1200 - Devices for imaging EC type-examination Annex III
- *MD 1202 - Imaging devices utilising non-ionizing EC verification Annex IV
radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III
- *MD 1301 - Monitoring devices of non-vital EC verification Annex IV
physiological parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III
- *MD 1302 - Monitoring devices of vital physiological EC verification Annex IV
parameters EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (full quality Annex V

assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III
therapy EC verification Annex IV
- *MD 1401 - Devices utilising ionizing radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III
therapy EC verification Annex IV
- *MD 1402 - Devices utilising non-ionizing radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III
therapy EC verification Annex IV
- *MD 1403 - Devices for hyperthermia / hypothermia EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III
therapy EC verification Annex IV
- *MD 1404 - Devices for (extracorporal) shock-wave EC declaration of Annex II
therapy (lithotripsy) conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1112 - Medical gas supply systems and parts EC verification Annex IV
thereof EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (full quality Annex V

assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam
sterilisation, moist heat
sterilisation, radiation sterilisation
(gamma, x-ray, electron beam)
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
Mit International Testing S.r.l. 0068
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III Medical Devices
Via G.Leopardi, 14
20123 - Milano (MI) medical devices conformity (full quality Annex V
Italy - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III Medical Devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices conformity (full quality Annex V

- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC verification Annex IV Excluding class III Medical Devices
medical devices EC declaration of Annex II
- *MD 0104 - Non-active medical devices with conformity (full quality Annex V
measuring function assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III Medical Devices
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III Medical Devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices conformity (full quality Annex V

- *MD 0106 - Non-active instruments assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III Medical Devices
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding class III Medical Devices
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III Medical Devices
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III Medical Devices
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III Medical Devices
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III Medical Devices
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III Medical Devices
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III Medical Devices
- *MD 1102 - Respiratory devices, devices including EC declaration of Annex II and hyperbaric chambers
hyperbaric chambers for oxygen therapy, inhalation conformity (full quality Annex V
anaesthesia assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC verification Annex IV Excluding class III Medical Devices
- *MD 1103 - Devices for stimulation or inhibition EC declaration of Annex II
conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III Medical Devices
- *MD 1104 - Active surgical devices EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III Medical Devices
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III Medical Devices
- *MD 1107 - Active devices for disinfection and EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

sterilisation conformity (full quality Annex V

assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III Medical Devices
- *MD 1108 - Active rehabilitation devices and active EC verification Annex IV
prostheses EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III Medical Devices
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III Medical Devices
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III Medical Devices
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III Medical Devices
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III Medical Devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III Excluding class III Medical Devices
therapy EC verification Annex IV
- *MD 1402 - Devices utilising non-ionizing radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III Medical Devices
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III Medical Devices
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7006 - Medical devices in sterile condition
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
BSI 0086
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
Kitemark Court Davy Avenue Knowlhill
Milton Keynes MK5 8PP medical devices system Annex III
United Kingdom - *MD 0101 - Non-active devices for anaesthesia, EC type-examination Annex IV
emergency and intensive care EC verification Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality
Annex VI
transfusion and dialysis assurance
- *MD 0103 - Non-active orthopaedic and rehabilitation Product quality assurance
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0109 - Non-active devices for in vitro fertilisation

(IVF) and assisted reproductive technologies (ART)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC verification Annex IV
- *MD 0110 - Non-active medical devices for ingestion EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0201 - Non-active cardiovascular implants system Annex III
- *MD 0202 - Non-active orthopaedic implants EC type-examination Annex IV
- *MD 0203 - Non-active functional implants EC verification Annex V
- *MD 0204 - Non-active soft tissue implants Production quality Annex VI
assurance
*MD 0300 - Devices for wound care
Product quality assurance
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0403 - Dental implants

*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1112 - Medical gas supply systems and parts EC verification Annex IV
thereof EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1201 - Imaging devices utilising ionizing system Annex III
radiation EC type-examination Annex IV
- *MD 1202 - Imaging devices utilising non-ionizing EC verification Annex V
radiation Production quality Annex VI
*MD 1300 - Monitoring devices assurance
- *MD 1301 - Monitoring devices of non-vital Product quality assurance
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

human blood, according to Directive 2000/70/EC,

amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
LLOYD'S REGISTER QUALITY ASSURANCE 0088
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
LTD (0088)
1 Trinity Park Bickenhill Lane medical devices system Annex V
Birmingham B37 7ES - *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
United Kingdom
transfusion and dialysis assurance
- *MD 0101 - Non-active devices for anaesthesia, Product quality assurance
emergency and intensive care
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0109 - Non-active devices for in vitro fertilisation

(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1107 - Active devices for disinfection and

sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
*MDS 7001 - Medical devices incorporating medicinal

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

substances, according to Directive 2001/83/EC

*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
SGS United Kingdom Limited 0120
*MD 1100 - General active medical devices EC declaration of Annex II
Unit 202B, Worle Parkway,
Weston-super-Mare, Somerset, BS22 6WA - *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
United Kingdom infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1102 - Respiratory devices, devices including system Annex V
hyperbaric chambers for oxygen therapy, inhalation Production quality Annex VI
anaesthesia assurance
Product quality assurance
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1104 - Active surgical devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1105 - Active ophthalmologic devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1106 - Active dental devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1107 - Active devices for disinfection and system Annex V
sterilisation Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1108 - Active rehabilitation devices and active system Annex V

prostheses Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1109 - Active devices for patient positioning and system Annex V
transport Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1110 - Active devices for in vitro fertilisation system Annex V
(IVF) and assisted reproductive therapy (ART) Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1111 - Software system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1201 - Imaging devices utilising ionizing system Annex V
radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1202 - Imaging devices utilising non-ionizing system Annex V
radiation Production quality Annex VI
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance
Product quality assurance
*MD 1300 - Monitoring devices EC declaration of Annex II
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1401 - Devices utilising ionizing radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1402 - Devices utilising non-ionizing radiation Production quality
39 / 344
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance Annex VI
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1404 - Devices for (extracorporal) shock-wave Production quality Annex VI
therapy (lithotripsy) assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0301 - Bandages and wound dressings system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0302 - Suture material and clamps system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0303 - Other medical devices for wound care system Annex V
Production quality Annex VI
assurance
Product quality assurance

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable Full quality assurance Annex II

medical devices system Annex V
- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
transfusion and dialysis assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation Production quality Annex VI
devices assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0104 - Non-active medical devices with Production quality Annex VI
measuring function assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0105 - Non-active ophthalmologic devices Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0106 - Non-active instruments Production quality Annex VI

assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0107 - Contraceptive medical devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0108 - Non-active medical devices for Production quality Annex VI
disinfecting, cleaning, rinsing assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0109 - Non-active devices for in vitro fertilisation Production quality Annex VI
(IVF) and assisted reproductive technologies (ART) assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II Excluding Breast Implants
- *MD 0204 - Non-active soft tissue implants system Annex V
Production quality Annex VI
assurance
Product quality assurance

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0200 - Non-active implants Full quality assurance Annex II

- *MD 0201 - Non-active cardiovascular implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0202 - Non-active orthopaedic implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0203 - Non-active functional implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0403 - Dental implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0401 - Non-active dental equipment and system Annex V
instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0402 - Dental materials system Annex V

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

Production quality Annex VI

assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7006 - Medical devices in sterile condition

*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
TÜV SÜD Product Service GmbH 0123
*MD 0300 - Devices for wound care Full quality assurance Annex II
Zertifizierstellen
Ridlerstraße 65 - *MD 0301 - Bandages and wound dressings system Annex V
80339 MÜNCHEN Production quality
- *MD 0302 - Suture material and clamps Annex VI
Germany
assurance
- *MD 0303 - Other medical devices for wound care
Product quality assurance
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1101 - Devices for extra-corporal circulation, system Annex III
infusion and haemopheresis EC type-examination Annex IV
- *MD 1102 - Respiratory devices, devices including EC verification Annex V
hyperbaric chambers for oxygen therapy, inhalation Production quality Annex VI
anaesthesia assurance
- *MD 1103 - Devices for stimulation or inhibition Product quality assurance
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1107 - Active devices for disinfection and

sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1110 - Active devices for in vitro fertilisation EC verification Annex IV
(IVF) and assisted reproductive therapy (ART) EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1201 - Imaging devices utilising ionizing system Annex III
radiation EC type-examination Annex IV
- *MD 1202 - Imaging devices utilising non-ionizing EC verification Annex V
radiation Production quality Annex VI
*MD 1300 - Monitoring devices assurance
- *MD 1301 - Monitoring devices of non-vital Product quality assurance
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation Production quality Annex VI
devices assurance
- *MD 0104 - Non-active medical devices with Product quality assurance
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex III

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0109 - Non-active devices for in vitro fertilisation EC type-examination Annex IV

(IVF) and assisted reproductive technologies (ART) EC verification Annex V
*MD 0200 - Non-active implants Production quality Annex VI
- *MD 0201 - Non-active cardiovascular implants assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0202 - Non-active orthopaedic implants system Annex V
- *MD 0203 - Non-active functional implants Production quality Annex VI
assurance
- *MD 0204 - Non-active soft tissue implants
Product quality assurance
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC verification Annex IV
- *MD 0110 - Non-active medical devices for ingestion EC declaration of Annex II
*MD 1100 - General active medical devices conformity (full quality Annex V
- *MD 1112 - Medical gas supply systems and parts assurance system)
Annex VI
thereof EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

human blood, according to Directive 2000/70/EC,

amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), moist heat sterilisation,
radiation sterilisation (gamma,
x-ray, electron beam), low
temperature steam and
formaldehyde sterilisation,
sterilisation with hydrogen
peroxide, thermic sterilisation with
dry heat, sterilisation with liquid
sterilants
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
DEKRA Certification GmbH 0124
*MD 0200 - Non-active implants Full quality assurance Annex II
Handwerkstraße 15
70565 STUTTGART - *MD 0201 - Non-active cardiovascular implants system Annex V
Germany Production quality
- *MD 0202 - Non-active orthopaedic implants Annex VI
assurance
- *MD 0203 - Non-active functional implants
Product quality assurance
- *MD 0204 - Non-active soft tissue implants

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0300 - Devices for wound care

- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1102 - Respiratory devices, devices including system Annex V
hyperbaric chambers for oxygen therapy, inhalation Production quality Annex VI
anaesthesia assurance
Product quality assurance
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
- *MD 1104 - Active surgical devices Annex VI
EC declaration of
- *MD 1105 - Active ophthalmologic devices
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1106 - Active dental devices conformity (production

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1107 - Active devices for disinfection and system Annex V
sterilisation Production quality Annex VI
- *MD 1108 - Active rehabilitation devices and active assurance
prostheses Product quality assurance
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1109 - Active devices for patient positioning and conformity (full quality Annex V
transport assurance system)
Annex VI
- *MD 1111 - Software EC declaration of
conformity (production
*MD 1200 - Devices for imaging
quality assurance)
- *MD 1201 - Imaging devices utilising ionizing
EC declaration of
radiation
conformity (product quality
- *MD 1202 - Imaging devices utilising non-ionizing
assurance)
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1401 - Devices utilising ionizing radiation Production quality Annex VI

51 / 344
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
- *MD 1403 - Devices for hyperthermia / hypothermia EC declaration of
conformity (production
- *MD 1404 - Devices for (extracorporal) shock-wave
quality assurance)
therapy (lithotripsy)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
- *MD 0102 - Non-active devices for injection, infusion, Product quality assurance
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0107 - Contraceptive medical devices assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0108 - Non-active medical devices for Production quality Annex VI
disinfecting, cleaning, rinsing assurance
- *MD 0109 - Non-active devices for in vitro fertilisation Product quality assurance
(IVF) and assisted reproductive technologies (ART)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

ethylene oxide gas sterilisation

(EOG), moist heat sterilisation,
radiation sterilisation (gamma,
x-ray, electron beam), low
temperature steam and
formaldehyde sterilisation,
sterilisation with hydrogen
peroxide, thermic sterilisation with
dry heat
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
TÜV Rheinland LGA Products GmbH 0197
*MD 0200 - Non-active implants Full quality assurance Annex II
Tillystraße 2
90431 Nürnberg - *MD 0201 - Non-active cardiovascular implants system Annex III
Germany EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0202 - Non-active orthopaedic implants system Annex V
- *MD 0203 - Non-active functional implants Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
54 / 344
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0204 - Non-active soft tissue implants system Annex III

EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0301 - Bandages and wound dressings system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0302 - Suture material and clamps system Annex III
EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0303 - Other medical devices for wound care system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0401 - Non-active dental equipment and system Annex III
instruments EC type-examination Annex IV

55 / 344
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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0402 - Dental materials system Annex V
- *MD 0403 - Dental implants Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1109 - Active devices for patient positioning and system Annex III
transport EC type-examination Annex IV
- *MD 1101 - Devices for extra-corporal circulation, EC verification Annex V
infusion and haemopheresis Production quality Annex VI
- *MD 1102 - Respiratory devices, devices including assurance
hyperbaric chambers for oxygen therapy, inhalation Product quality assurance
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)

56 / 344
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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1111 - Software

*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
transfusion and dialysis assurance
- *MD 0103 - Non-active orthopaedic and rehabilitation Product quality assurance
devices
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex III
- *MD 0104 - Non-active medical devices with EC type-examination Annex IV
measuring function EC verification Annex V
- *MD 0105 - Non-active ophthalmologic devices Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0106 - Non-active instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex III
- *MD 0107 - Contraceptive medical devices EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices system Annex V

- *MD 0108 - Non-active medical devices for Production quality Annex VI
disinfecting, cleaning, rinsing assurance
- *MD 0109 - Non-active devices for in vitro fertilisation Product quality assurance
(IVF) and assisted reproductive technologies (ART)
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1201 - Imaging devices utilising ionizing system Annex III
radiation EC type-examination Annex IV
- *MD 1202 - Imaging devices utilising non-ionizing EC verification Annex V
radiation Production quality Annex VI
*MD 1300 - Monitoring devices assurance
- *MD 1301 - Monitoring devices of non-vital Product quality assurance
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI

58 / 344
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1112 - Medical gas supply systems and parts EC verification Annex IV
thereof EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive for active medical devices only
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), moist heat sterilisation,
radiation sterilisation (gamma,

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

electron beam), low temperature

steam and formaldehyde
sterilisation, sterilisation with
hydrogen peroxide, thermic
sterilisation with dry heat,
sterilisation by liquid chemical
sterilants
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
DQS Medizinprodukte GmbH 0297
*MD 1200 - Devices for imaging Full quality assurance Annex II
August-Schanz-Straße 21
60433 FRANKFURT AM MAIN - *MD 1201 - Imaging devices utilising ionizing system Annex V
Germany radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1202 - Imaging devices utilising non-ionizing system Annex V
radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1300 - Monitoring devices Full quality assurance Annex II
- *MD 1301 - Monitoring devices of non-vital system Annex V
physiological parameters Production quality Annex VI

60 / 344
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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance
Product quality assurance
*MD 1300 - Monitoring devices Full quality assurance Annex II
- *MD 1302 - Monitoring devices of vital physiological system Annex V
parameters Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1401 - Devices utilising ionizing radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1402 - Devices utilising non-ionizing radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1404 - Devices for (extracorporal) shock-wave Production quality Annex VI
therapy (lithotripsy) assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality
transfusion and dialysis assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II

61 / 344
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices system Annex V

- *MD 0101 - Non-active devices for anaesthesia, Production quality
emergency and intensive care assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation Production quality
devices assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0104 - Non-active medical devices with Production quality
measuring function assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0105 - Non-active ophthalmologic devices Production quality
assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0106 - Non-active instruments Production quality
assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0108 - Non-active medical devices for Production quality
disinfecting, cleaning, rinsing assurance
*MD 0200 - Non-active implants Full quality assurance Annex II vascular implants only
- *MD 0201 - Non-active cardiovascular implants system Annex V
Production quality
assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0200 - Non-active implants Full quality assurance Annex II

- *MD 0202 - Non-active orthopaedic implants system Annex V
Production quality
assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0203 - Non-active functional implants system Annex V
Production quality
assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0204 - Non-active soft tissue implants system Annex V
Production quality
assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0301 - Bandages and wound dressings system Annex V
Production quality
assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0302 - Suture material and clamps system Annex V
Production quality
assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0303 - Other medical devices for wound care system Annex V
Production quality
assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0401 - Non-active dental equipment and system Annex V
instruments Production quality

63 / 344
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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0402 - Dental materials system Annex V
Production quality
assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0403 - Dental implants system Annex V
Production quality
assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1104 - Active surgical devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1105 - Active ophthalmologic devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1106 - Active dental devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1107 - Active devices for disinfection and system Annex V
sterilisation Production quality Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1108 - Active rehabilitation devices and active system Annex V
prostheses Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1109 - Active devices for patient positioning and system Annex V
transport Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1111 - Software system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1101 - Devices for extra-corporal circulation, system Annex V
infusion and haemopheresis Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1102 - Respiratory devices, devices including system Annex V
hyperbaric chambers for oxygen therapy, inhalation Production quality Annex VI
anaesthesia assurance
Product quality assurance

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1103 - Devices for stimulation or inhibition system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0107 - Contraceptive medical devices assurance system)
EC declaration of
conformity (production
quality assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7002 - Medical devices utilising tissues of animal

origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), moist heat sterilisation,
radiation sterilisation (gamma,
x-ray, electron beam), low
temperature steam and
formaldehyde sterilisation,
sterilisation with hydrogen
peroxide, thermic sterilisation with
dry heat
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
AGENCIA ESPAÑOLA DE MEDICAMENTOS 0318
*MD 1200 - Devices for imaging EC type-examination Annex III
Y PRODUCTOS SANITARIOS
Campezo 1. Edificio 8 - *MD 1201 - Imaging devices utilising ionizing EC verification Annex IV
28022 MADRID radiation EC declaration of Annex II
Spain
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
*MD 1300 - Monitoring devices EC declaration of

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1301 - Monitoring devices of non-vital conformity (production

physiological parameters quality assurance)
- *MD 1302 - Monitoring devices of vital physiological EC declaration of
parameters conformity (product quality
*MD 1400 - Devices for radiation therapy and thermo assurance)
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

(IVF) and assisted reproductive technologies (ART)

*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

(IVF) and assisted reproductive therapy (ART)

- *MD 1111 - Software
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7005 - Medical devices referencing the Directive
89/686/EEC on personal protective equipment (PPE)
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
DEKRA Certification B.V. 0344
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
Meander 1051 / P.O. Box 5185
6825 MJ ARNHEM / 6802 ED ARNHEM medical devices EC verification Annex IV
Netherlands - *MD 0101 - Non-active devices for anaesthesia, EC declaration of Annex II
emergency and intensive care conformity (full quality Annex V
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
- *MD 0103 - Non-active orthopaedic and rehabilitation conformity (production
devices quality assurance)
- *MD 0104 - Non-active medical devices with EC declaration of
measuring function conformity (product quality
- *MD 0105 - Non-active ophthalmologic devices assurance)

- *MD 0106 - Non-active instruments

- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0403 - Dental implants

*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1106 - Active dental devices

- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
- *MD 1112 - Medical gas supply systems and parts
thereof
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
ISTITUTO SUPERIORE DI SANITA' 0373
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
Viale Regina Elena, 299
00161 - ROMA medical devices conformity (full quality Annex V
Italy - *MD 0101 - Non-active devices for anaesthesia, assurance system)
emergency and intensive care EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system)
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system)
devices EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
measuring function EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Annex III limited to ophthalmic

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices EC declaration of Annex II solutions

- *MD 0105 - Non-active ophthalmologic devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0107 - Contraceptive medical devices assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices conformity (full quality Annex V

- *MD 0110 - Non-active medical devices for ingestion assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0201 - Non-active cardiovascular implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC type-examination Annex III Annex III limited to injectable
- *MD 0203 - Non-active functional implants EC declaration of Annex II visco-elastic solutions for
conformity (full quality intra-articular use
Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC type-examination Annex III Annex III limited intradermal fillers
- *MD 0204 - Non-active soft tissue implants EC declaration of Annex II
conformity (full quality Annex V
assurance system)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0402 - Dental materials conformity (full quality Annex V

assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1104 - Active surgical devices conformity (full quality
assurance system)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III Limited to accelerator for hadron
therapy EC verification Annex IV therapy and related dose delivery
- *MD 1401 - Devices utilising ionizing radiation system

*MDS 7001 - Medical devices incorporating medicinal

substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam,
moist heat sterilisation, radiation
sterelisation (gamma, electron
beam)

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7009 - Medical devices utilising biological active

coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
RISE Research Institutes of Sweden AB 0402
*MD 1200 - Devices for imaging Full quality assurance Annex II
Box 857
501 15 BORAS - *MD 1201 - Imaging devices utilising ionizing system Annex V
Sweden radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1300 - Monitoring devices Full quality assurance Annex II
- *MD 1301 - Monitoring devices of non-vital system Annex V
physiological parameters Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0104 - Non-active medical devices with Production quality Annex VI
measuring function assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0106 - Non-active instruments Production quality Annex VI

assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II Bone-anchored implants for dental
- *MD 0203 - Non-active functional implants system Annex V and cranio-facial reconstruction
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0401 - Non-active dental equipment and system Annex V
instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II Bone-anchored implants for dental
- *MD 0403 - Dental implants system Annex V and cranio-facial reconstruction
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1102 - Respiratory devices, devices including system Annex V
hyperbaric chambers for oxygen therapy, inhalation Production quality Annex VI
anaesthesia assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1106 - Active dental devices system Annex V
Production quality Annex VI
assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

Product quality assurance

*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable EC declaration of Annex II

medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

prostheses assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
TÜV AUSTRIA SERVICES GMBH 0408
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
Deutschstraße 10
1230 WIEN medical devices EC verification Annex IV
Austria - *MD 0101 - Non-active devices for anaesthesia, EC declaration of Annex II
emergency and intensive care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC verification Annex IV
- *MD 0102 - Non-active devices for injection, infusion, EC declaration of Annex II
transfusion and dialysis conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC verification Annex IV
- *MD 0103 - Non-active orthopaedic and rehabilitation EC declaration of Annex II
devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC verification Annex IV
- *MD 0104 - Non-active medical devices with EC declaration of Annex II
measuring function conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable EC type-examination Annex III

medical devices EC verification Annex IV
- *MD 0105 - Non-active ophthalmologic devices EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC verification Annex IV
- *MD 0106 - Non-active instruments EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC verification Annex IV
- *MD 0107 - Contraceptive medical devices EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC verification Annex IV
- *MD 0108 - Non-active medical devices for EC declaration of Annex II
disinfecting, cleaning, rinsing conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC verification Annex IV
- *MD 0109 - Non-active devices for in vitro fertilisation EC declaration of Annex II
(IVF) and assisted reproductive technologies (ART) conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0200 - Non-active implants EC type-examination Annex III

- *MD 0202 - Non-active orthopaedic implants EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC type-examination Annex III neurological and neurosurgical
- *MD 0203 - Non-active functional implants EC verification Annex IV implants excluded

EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC type-examination Annex III
- *MD 0301 - Bandages and wound dressings EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC type-examination Annex III
- *MD 0302 - Suture material and clamps EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC type-examination Annex III
- *MD 0303 - Other medical devices for wound care EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0400 - Non-active dental devices and accessories EC type-examination Annex III
- *MD 0401 - Non-active dental equipment and EC verification Annex IV
instruments EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC type-examination Annex III
- *MD 0402 - Dental materials EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC type-examination Annex III
- *MD 0403 - Dental implants EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1101 - Devices for extra-corporal circulation, EC verification Annex IV
infusion and haemopheresis EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1102 - Respiratory devices, devices including EC verification Annex IV
hyperbaric chambers for oxygen therapy, inhalation EC declaration of Annex II
anaesthesia conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC type-examination Annex III

- *MD 1103 - Devices for stimulation or inhibition EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1104 - Active surgical devices EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1105 - Active ophthalmologic devices EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1106 - Active dental devices EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1107 - Active devices for disinfection and EC verification Annex IV
sterilisation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC type-examination Annex III

- *MD 1108 - Active rehabilitation devices and active EC verification Annex IV
prostheses EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1109 - Active devices for patient positioning and EC verification Annex IV
transport EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1110 - Active devices for in vitro fertilisation EC verification Annex IV
(IVF) and assisted reproductive therapy (ART) EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1111 - Software EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC type-examination Annex III
- *MD 1201 - Imaging devices utilising ionizing EC verification Annex IV
radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1200 - Devices for imaging EC type-examination Annex III

- *MD 1202 - Imaging devices utilising non-ionizing EC verification Annex IV
radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III
- *MD 1301 - Monitoring devices of non-vital EC verification Annex IV
physiological parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III
- *MD 1302 - Monitoring devices of vital physiological EC verification Annex IV
parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III
therapy EC verification Annex IV
- *MD 1401 - Devices utilising ionizing radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III
therapy EC verification Annex IV
- *MD 1402 - Devices utilising non-ionizing radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III
therapy EC verification Annex IV
- *MD 1403 - Devices for hyperthermia / hypothermia EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III
therapy EC verification Annex IV
- *MD 1404 - Devices for (extracorporal) shock-wave EC declaration of Annex II
therapy (lithotripsy) conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal tissues according directive
origin, including Regulation 722/2012 (Directive 2003/32/EC excluded
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

human blood, according to Directive 2000/70/EC,

amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
INTERTEK SEMKO AB 0413
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
Torshamnsgatan 43 Box 1103
SE-164 22 KISTA medical devices conformity (full quality Annex V
Sweden - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
transfusion and dialysis assurance
- *MD 0103 - Non-active orthopaedic and rehabilitation Product quality assurance
devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0104 - Non-active medical devices with

measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
- *MD 1102 - Respiratory devices, devices including EC declaration of
hyperbaric chambers for oxygen therapy, inhalation conformity (production
anaesthesia quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1103 - Devices for stimulation or inhibition EC declaration of

- *MD 1104 - Active surgical devices conformity (product quality
assurance)
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7004 - Medical devices referencing the Directive

2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
ICIM S.P.A. 0425
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
Piazza Don Enrico Mapelli, 75
20099 - Sesto San Giovanni (MI) medical devices conformity (full quality Annex V devices
Italy - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0302 - Suture material and clamps conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V devices
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0402 - Dental materials conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0403 - Dental implants conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V devices and hyperbaric chambers
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1106 - Active dental devices conformity (full quality Annex V devices
assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V devices
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1111 - Software conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Exclusion of class III medical
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V devices

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

physiological parameters assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Exclusion of class III medical
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V devices
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V devices
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam and

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

formaldehyde sterilisation, moist

heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam), others (need to be
specified)
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
ITALCERT SRL 0426
*MD 1300 - Monitoring devices EC declaration of Annex II Exclusion of class III medical
Viale Sarca, 336
20126 - MILANO - *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V devices
Italy physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Exclusion of class III medical
therapy conformity (full quality Annex V devices
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Exclusion of class III medical
therapy conformity (full quality Annex V devices
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices, except surgically devices,
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
intended for transient use, in direct
transfusion and dialysis EC declaration of contact with central nervous
conformity (production system
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Exclusion of class III medical
- *MD 0203 - Non-active functional implants conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Exclusion of class III medical
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0302 - Suture material and clamps conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V devices
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0402 - Dental materials conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1111 - Software conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V devices
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V devices
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1104 - Active surgical devices conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V devices
assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1106 - Active dental devices conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V devices
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

prostheses assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V devices
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7002 - Medical devices utilising tissues of animal Exclusion of medical devices
origin, including Regulation 722/2012 (Directive utilising tissues of animal origin
2003/32/EC up to 28.08.2013) under Commission Regulation

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

(EU) n. 722/2012
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
Laboratoire national de métrologie et d'essais / 0459
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
G-MED
1, rue Gaston Boissier medical devices system Annex III
75724 PARIS Cedex 15 - *MD 0101 - Non-active devices for anaesthesia, EC type-examination Annex IV
France
emergency and intensive care EC verification Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality
Annex VI
transfusion and dialysis assurance
- *MD 0103 - Non-active orthopaedic and rehabilitation Product quality assurance
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable EC type-examination Annex III

medical devices EC verification Annex IV
- *MD 0110 - Non-active medical devices for ingestion EC declaration of Annex II
*MD 0200 - Non-active implants conformity (full quality Annex V
- *MD 0201 - Non-active cardiovascular implants assurance system)
Annex VI
- *MD 0202 - Non-active orthopaedic implants EC declaration of
conformity (production
- *MD 0203 - Non-active functional implants
quality assurance)
- *MD 0204 - Non-active soft tissue implants
EC declaration of
*MD 0300 - Devices for wound care
conformity (product quality
- *MD 0301 - Bandages and wound dressings assurance)
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1106 - Active dental devices

- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1111 - Software EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1112 - Medical gas supply systems and parts EC verification Annex IV
thereof EC declaration of Annex II
*MD 1200 - Devices for imaging conformity (full quality Annex V
- *MD 1201 - Imaging devices utilising ionizing assurance system)
Annex VI
radiation EC declaration of
- *MD 1202 - Imaging devices utilising non-ionizing conformity (production
radiation quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1300 - Monitoring devices EC declaration of

- *MD 1301 - Monitoring devices of non-vital conformity (product quality
physiological parameters assurance)

- *MD 1302 - Monitoring devices of vital physiological

parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Chemical sterilization/Dry heat
sterilization/Hydrogen peroxid with
or without plasma process
sterilization/Ultra High
Temperature Infusion sterilization
process
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7009 - Medical devices utilising biological active

coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
AMTAC CERTIFICATION SERVICES LTD 0473
*MD 0200 - Non-active implants Full quality assurance Annex II
Davy Avenue, Knowlhill
Milton Keynes MK5 8NL - *MD 0201 - Non-active cardiovascular implants system Annex V
United Kingdom Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0202 - Non-active orthopaedic implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0203 - Non-active functional implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II Excluding breast implants
- *MD 0204 - Non-active soft tissue implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0401 - Non-active dental equipment and system Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

instruments Production quality Annex VI

assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II Excluding Class III
- *MD 0402 - Dental materials system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II Excluding Class III
- *MD 0403 - Dental implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding Class III
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7006 - Medical devices in sterile condition
KIWA CERMET ITALIA S.P.A. 0476
*MD 0200 - Non-active implants EC declaration of Annex II Excluding class III medical devices,
Via Cadriano, 23
40057 - Cadriano di Granarolo (BO) - *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V except hip, knee and shoulder joint
Italy assurance system) replacements.
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding class III medical devices
- *MD 0203 - Non-active functional implants conformity (full quality Annex V
assurance system)
Annex VI
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding class III medical devices
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III medical devices
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III medical devices
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III medical devices
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices,
medical devices conformity (full quality Annex V except surgically devices, intended
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
for transient use, in direct contact
transfusion and dialysis EC declaration of with central nervous system
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0107 - Contraceptive medical devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V and hyperbaric chambers for
hyperbaric chambers for oxygen therapy, inhalation assurance system) oxygen therapy
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1109 - Active devices for patient positioning and conformity (full quality Annex V
transport assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III medical devices
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V and devices for magnetic

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

radiation assurance system) Annex VI resonance

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III medical devices
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III medical devices
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III medical devices
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III medical devices
therapy conformity (full quality Annex V
- *MD 1404 - Devices for (extracorporal) shock-wave assurance system) Annex VI
therapy (lithotripsy) EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive Excluding class III medical devices
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Excluding class III medical devices,
except surgically devices, intended
for transient use, in direct contact
with central nervous system; hip,
knee and shoulder joint
replacements
Eurofins Product Testing Italy S.r.l. 0477
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
Via Courgnè, 21
10156 - TORINO (TO) medical devices conformity (full quality Annex V
Italy - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Excluding class III medical devices
medical devices EC verification Annex IV
- *MD 0102 - Non-active devices for injection, infusion, EC declaration of Annex II
transfusion and dialysis conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Excluding class III medical devices
medical devices EC verification Annex IV
- *MD 0105 - Non-active ophthalmologic devices EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Excluding class III medical devices
medical devices EC verification Annex IV
- *MD 0106 - Non-active instruments EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Excluding class III medical devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices EC verification Annex IV

- *MD 0107 - Contraceptive medical devices EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Excluding class III medical devices
medical devices EC verification Annex IV
- *MD 0108 - Non-active medical devices for EC declaration of Annex II
disinfecting, cleaning, rinsing conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding class III medical devices
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0200 - Non-active implants EC type-examination Annex III Excluding class III medical devices
- *MD 0203 - Non-active functional implants EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC type-examination Annex III Excluding class III medical devices
- *MD 0301 - Bandages and wound dressings EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC type-examination Annex III Excluding class III medical devices
- *MD 0302 - Suture material and clamps EC verification Annex IV
EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (full quality Annex V

assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC type-examination Annex III Excluding class III medical devices
- *MD 0303 - Other medical devices for wound care EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC type-examination Annex III Excluding class III medical devices
- *MD 0401 - Non-active dental equipment and EC verification Annex IV
instruments EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0400 - Non-active dental devices and accessories EC type-examination Annex III Excluding class III medical devices
- *MD 0402 - Dental materials EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC type-examination Annex III Excluding class III medical devices
- *MD 0403 - Dental implants EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Only class IIa medical devices
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1109 - Active devices for patient positioning and conformity (full quality Annex V
transport assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III medical devices
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III medical devices
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V and devices for magnetic
radiation assurance system) resonance
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III medical devices
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III medical devices
therapy conformity (full quality Annex V
- *MD 1401 - Devices utilising ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III medical devices
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III medical devices
therapy conformity (full quality Annex V
- *MD 1404 - Devices for (extracorporal) shock-wave assurance system) Annex VI
therapy (lithotripsy) EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7004 - Medical devices referencing the Directive Excluding class III medical devices
2006/42/EC on machinery
*MDS 7005 - Medical devices referencing the Directive Excluding class III medical devices
89/686/EEC on personal protective equipment (PPE)
*MDS 7006 - Medical devices in sterile condition Excluding class III medical devices
ecm-Zertifizierungsgesellschaft für 0481
*MD 0200 - Non-active implants Full quality assurance Annex II Only stents, implantable catheters,
Medizinprodukte in Europa mbH
Bismarckstraße 106 - *MD 0201 - Non-active cardiovascular implants system Annex III vascular grafts, occlusion systems
52066 Aachen EC type-examination Annex V
Germany
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0202 - Non-active orthopaedic implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II Only introcular lenses
- *MD 0203 - Non-active functional implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0204 - Non-active soft tissue implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices system Annex V

- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II Annex III: Only infusion sets,
medical devices system Annex III transfusion sets, catheters, tubing
- *MD 0102 - Non-active devices for injection, infusion, EC type-examination systems for extra-corporal
Annex V
transfusion and dialysis circulation
Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation Production quality Annex VI
devices assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0104 - Non-active medical devices with Production quality Annex VI
measuring function assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0105 - Non-active ophthalmologic devices Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0106 - Non-active instruments Production quality Annex VI

assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0107 - Contraceptive medical devices Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0108 - Non-active medical devices for Production quality Annex VI
disinfecting, cleaning, rinsing assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0109 - Non-active devices for in vitro fertilisation Production quality Annex VI
(IVF) and assisted reproductive technologies (ART) assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0301 - Bandages and wound dressings system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0302 - Suture material and clamps system Annex V
Production quality Annex VI
assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

Product quality assurance

*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0303 - Other medical devices for wound care system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0401 - Non-active dental equipment and system Annex V
instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0402 - Dental materials system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0403 - Dental implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II only products, which are based on
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V spring tension (pre-loaded) or gas
infusion and haemopheresis assurance system) release for pressure build-up, e.g.
Annex VI
EC declaration of drug dosers
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II only wound drainage systems and
- *MD 1104 - Active surgical devices conformity (full quality Annex V accessories for HF surgery (e.g.
assurance system) scissors, pliers)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Only medical devices in small
therapy conformity (full quality Annex V pressure vessels (e.g. coolant
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
sprays) for localized application
EC declaration of and medical devices, where heat
conformity (production or cold is generated by chemical or
quality assurance) physical processes (e.g. hot/cold
packs) for localized application
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal Only devices with existing TSE
origin, including Regulation 722/2012 (Directive Certificate of Suitability for the
2003/32/EC up to 28.08.2013) starting materials issued by the
European Directorate for the
Qualits of Medicines (EDQM)
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), moist heat sterilisation,
radiation sterilisation (gamma,
x-ray, electron beam), low
temperature steam and
formaldehyde sterilisation,
sterilisation with hydrogen
peroxide, thermic sterilisation with
dry heat
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
MEDCERT ZERTIFIZIERUNGS- UND 0482
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
PRÜFUNGSGESELLSCHAFT FÜR DIE
MEDIZIN GMBH medical devices EC declaration of Annex II
Pilatuspool 2 - *MD 0101 - Non-active devices for anaesthesia, conformity (full quality Annex V
20355 HAMBURG
Germany
emergency and intensive care assurance system)
Annex VI
- *MD 0102 - Non-active devices for injection, infusion, EC declaration of
transfusion and dialysis conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
- *MD 0104 - Non-active medical devices with conformity (production
measuring function quality assurance)

- *MD 0105 - Non-active ophthalmologic devices EC declaration of

conformity (product quality
- *MD 0106 - Non-active instruments
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC declaration of Annex II
- *MD 0107 - Contraceptive medical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
- *MD 0109 - Non-active devices for in vitro fertilisation conformity (production
(IVF) and assisted reproductive technologies (ART) quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC type-examination Annex III
- *MD 0201 - Non-active cardiovascular implants EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC type-examination Annex III
- *MD 0203 - Non-active functional implants EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC type-examination Annex III
- *MD 0301 - Bandages and wound dressings EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
- *MD 0303 - Other medical devices for wound care Annex VI
EC declaration of
*MD 0400 - Non-active dental devices and accessories
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0401 - Non-active dental equipment and quality assurance)

instruments EC declaration of
- *MD 0402 - Dental materials conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC type-examination Annex III
- *MD 0403 - Dental implants EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
- *MD 1102 - Respiratory devices, devices including EC declaration of
hyperbaric chambers for oxygen therapy, inhalation conformity (production
anaesthesia quality assurance)

- *MD 1103 - Devices for stimulation or inhibition EC declaration of

conformity (product quality
- *MD 1104 - Active surgical devices
assurance)
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0110 - Non-active medical devices for ingestion
*MD 1100 - General active medical devices
- *MD 1112 - Medical gas supply systems and parts
thereof

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7001 - Medical devices incorporating medicinal

substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive for active medical devices only
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), moist heat sterilisation,
radiation sterilisation (gamma,
x-ray, electron beam), low
temperature steam and
formaldehyde sterilisation,
sterilisation with hydrogen
peroxide, thermic sterilisation with
dry heat
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
MDC MEDICAL DEVICE CERTIFICATION 0483
*MD 0200 - Non-active implants Full quality assurance Annex II
GMBH
Kriegerstrasse 6 - *MD 0201 - Non-active cardiovascular implants system Annex V
70191 STUTTGART Production quality Annex VI
Germany
assurance
Product quality assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0200 - Non-active implants EC declaration of Annex II

- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0204 - Non-active soft tissue implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0203 - Non-active functional implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0301 - Bandages and wound dressings system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0302 - Suture material and clamps system Annex V
Production quality Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0303 - Other medical devices for wound care system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1401 - Devices utilising ionizing radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1402 - Devices utilising non-ionizing radiation Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0107 - Contraceptive medical devices Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0108 - Non-active medical devices for Production quality Annex VI
disinfecting, cleaning, rinsing assurance
Product quality assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable Full quality assurance Annex II

medical devices system Annex V
- *MD 0109 - Non-active devices for in vitro fertilisation Production quality Annex VI
(IVF) and assisted reproductive technologies (ART) assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
transfusion and dialysis assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation Production quality Annex VI
devices assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0104 - Non-active medical devices with Production quality Annex VI
measuring function assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0105 - Non-active ophthalmologic devices Production quality Annex VI

assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0106 - Non-active instruments Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1201 - Imaging devices utilising ionizing system Annex V
radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1202 - Imaging devices utilising non-ionizing system Annex V
radiation Production quality Annex VI
assurance
Product quality assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1300 - Monitoring devices Full quality assurance Annex II

- *MD 1301 - Monitoring devices of non-vital system Annex V
physiological parameters Production quality Annex VI
assurance
Product quality assurance
*MD 1300 - Monitoring devices Full quality assurance Annex II
- *MD 1302 - Monitoring devices of vital physiological system Annex V
parameters Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0401 - Non-active dental equipment and system Annex V
instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0402 - Dental materials system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0403 - Dental implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1107 - Active devices for disinfection and system Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

sterilisation Production quality Annex VI

assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1108 - Active rehabilitation devices and active system Annex V
prostheses Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1109 - Active devices for patient positioning and system Annex V
transport Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1111 - Software system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II except hyperbaric chambers
- *MD 1102 - Respiratory devices, devices including system Annex V
hyperbaric chambers for oxygen therapy, inhalation Production quality Annex VI
anaesthesia assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II except external pacemakers and
- *MD 1103 - Devices for stimulation or inhibition system Annex V heart defibrillators
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1104 - Active surgical devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1105 - Active ophthalmologic devices system Annex V
Production quality Annex VI
assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

Product quality assurance

*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1106 - Active dental devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), moist heat sterilisation,
radiation sterilisation (gamma,
x-ray, electron beam), low
temperature steam and

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

formaldehyde sterilisation,
sterilisation with hydrogen
peroxide, thermic sterilisation with
dry heat
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
SLG PRÜF UND ZERTIFIZIERUNGS GMBH 0494
*MD 1100 - General active medical devices Full quality assurance Annex II excluding class III devices (valid for
Burgstädter Strasse 20
09232 Hartmannsdorf - *MD 1103 - Devices for stimulation or inhibition system Annex III the complete scope)
Germany EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II excluding class III devices (valid for
- *MD 1102 - Respiratory devices, devices including system Annex III the complete scope)
hyperbaric chambers for oxygen therapy, inhalation EC type-examination Annex IV
anaesthesia EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II excluding class III devices (valid for
- *MD 1104 - Active surgical devices system Annex III the complete scope)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II excluding class III devices (valid for
- *MD 1105 - Active ophthalmologic devices system Annex III the complete scope)
EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II excluding class III devices (valid for
- *MD 1106 - Active dental devices system Annex III the complete scope)
EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices EC type-examination Annex III excluding class III devices (valid for
- *MD 1112 - Medical gas supply systems and parts EC verification Annex IV the complete scope)
thereof EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II excluding class III devices (valid for
- *MD 1108 - Active rehabilitation devices and active system Annex III the complete scope)
prostheses EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II excluding class III devices (valid for
- *MD 1109 - Active devices for patient positioning and system Annex III the complete scope)
transport EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II excluding class III devices (valid for
- *MD 1111 - Software system Annex III the complete scope)
EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II excluding class III devices (valid for
- *MD 1201 - Imaging devices utilising ionizing system Annex III the complete scope)
radiation EC type-examination
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC verification Annex IV
Production quality Annex V
assurance Annex VI
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II excluding class III devices (valid for
- *MD 1202 - Imaging devices utilising non-ionizing system Annex III the complete scope)
radiation EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1300 - Monitoring devices Full quality assurance Annex II excluding class III devices (valid for
- *MD 1301 - Monitoring devices of non-vital system Annex III the complete scope)
physiological parameters EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1300 - Monitoring devices Full quality assurance Annex II excluding class III devices (valid for
- *MD 1302 - Monitoring devices of vital physiological system Annex III the complete scope)
parameters EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II excluding class III devices (valid for

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

therapy system Annex III the complete scope)

- *MD 1401 - Devices utilising ionizing radiation EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II excluding class III devices (valid for
therapy system Annex III the complete scope)
- *MD 1402 - Devices utilising non-ionizing radiation EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II excluding class III devices (valid for
therapy system Annex III the complete scope)
- *MD 1403 - Devices for hyperthermia / hypothermia EC type-examination Annex IV
EC verification Annex V
Production quality Annex VI
assurance
Product quality assurance
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
VTT Expert Services Oy 0537
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III
PO Box 345
FI-33101 Tampere medical devices conformity (full quality Annex V
Finland assurance system)
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0101 - Non-active devices for anaesthesia, EC declaration of Annex VI

emergency and intensive care conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding class III
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III
- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1111 - Software conformity (full quality Annex V

assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III
therapy conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive Excluding class III
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam and
formaldehyde sterilisation, moist
heat sterilisation (gamma, x-ray,
electron beam), others (need to be
specified)
Presafe Denmark A/S 0543
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
Tuborg Parkvej 8
DK-2900 Hellerup medical devices conformity (full quality Annex V
Denmark - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

transfusion and dialysis EC declaration of

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0109 - Non-active devices for in vitro fertilisation assurance system) Annex VI
(IVF) and assisted reproductive technologies (ART) EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding orthopaedic implants ref.
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V 2005/50/EEC and bone cement
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0203 - Non-active functional implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1110 - Active devices for in vitro fertilisation conformity (full quality Annex V
(IVF) and assisted reproductive therapy (ART) assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC declaration of Annex II

- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V

physiological parameters assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7002 - Medical devices utilising tissues of animal Only products not included in
origin, including Regulation 722/2012 (Directive Directive 2003/32/EC
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
CERTIQUALITY S.R.L. - ISTITUTO DI 0546
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
CERTIFICAZIONE DELLA QUALITA'
Via G. Giardino, 4 medical devices conformity (full quality Annex V devices, except those classified in
20123 - MILANO - *MD 0101 - Non-active devices for anaesthesia, assurance system) class III only as incorporating
Annex VI
Italy medicinal substances, according to
emergency and intensive care EC declaration of
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices, except those classified in
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
class III only as incorporating
transfusion and dialysis EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance) utilising biological active coatings

EC declaration of and/or materials or being wholly or
conformity (product quality mainly absorbed
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices, except those classified in
- *MD 0105 - Non-active ophthalmologic devices assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Exclusion of class III medical
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Exclusion of class III medical
- *MD 0203 - Non-active functional implants conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Exclusion of class III medical
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0302 - Suture material and clamps conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Exclusion of class III medical
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V devices
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0402 - Dental materials conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Exclusion of class III medical
- *MD 0403 - Dental implants conformity (full quality Annex V devices, except those classified in
assurance system) class III only as incorporating
Annex VI
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC and/or
quality assurance) utilising biological active coatings
and/or materials or being wholly or
EC declaration of
mainly absorbed
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding hyperbaric chambers
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V and all devices depending on a
hyperbaric chambers for oxygen therapy, inhalation assurance system) source of electrical energy.
Annex VI
anaesthesia EC declaration of Exclusion of class III medical
conformity (production devices, except those classified in
quality assurance) Class III only as incorporating
medicinal substances, according to
EC declaration of
Directive 2001/83/EC
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1111 - Software conformity (full quality Annex V devices
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding medical devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

therapy conformity (full quality Annex V depending on a source of electrical

- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI energy. Exclusion of class III
EC declaration of medical devices, except those
conformity (production classified in Class III only as
quality assurance) incorporating medicinal
substances, according to Directive
EC declaration of
2001/83/EC
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion of class III medical
medical devices conformity (full quality Annex V devices, except those classified in
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
Class III only as incorporating
EC declaration of medicinal substances, according to
conformity (production Directive 2001/83/EC
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V devices
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7006 - Medical devices in sterile condition

*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
SGS FIMKO OY 0598
*MD 0100 - General non-active, non-implantable EC declaration of Annex II II: Up to class IIb only
P.O. Box 30 (Särkiniementie 3)
00211 HELSINKI medical devices conformity (full quality Annex V
Finland - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II II: Up to class IIb only
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II II: Up to class IIb only
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II II: Up to class IIb only
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II II: Up to class IIb only
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II II: Up to class IIb only
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II II: Up to class IIb only
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II II: Up to class IIb only
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II II: Up to class IIb only
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III II: Up to class IIb only; III, IV:
- *MD 1102 - Respiratory devices, devices including EC verification Annex IV Hyperbaric chambers only
hyperbaric chambers for oxygen therapy, inhalation EC declaration of Annex II
anaesthesia conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III II: Up to class IIb only; III, IV: Nerve
- *MD 1103 - Devices for stimulation or inhibition EC verification Annex IV and muscle stimulator only

EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II II: Up to class IIb only
- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V
assurance system)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of Annex VI
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III II: Up to class IIb only; III, IV:
- *MD 1106 - Active dental devices EC verification Annex IV Dental units and dental patient
chairs only
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II II: Up to class IIb only
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III II: Up to class IIb only; III, IV:
- *MD 1108 - Active rehabilitation devices and active EC verification Annex IV Neurological and muscular

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

prostheses EC declaration of Annex II rehabilitation devices only

conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III II: Up to class IIb only
- *MD 1109 - Active devices for patient positioning and EC verification Annex IV
transport EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II II: Up to class IIb only
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1200 - Devices for imaging EC type-examination Annex III II: Up to class IIb only; III, IV: X-ray
- *MD 1201 - Imaging devices utilising ionizing EC verification Annex IV devices only
radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC type-examination Annex III II: Up to class IIb only; III, IV:
- *MD 1202 - Imaging devices utilising non-ionizing EC verification Annex IV Magnetic resonance imaging (MRI)
radiation devices only
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III II: Up to class IIb only
- *MD 1301 - Monitoring devices of non-vital EC verification Annex IV
physiological parameters EC declaration of Annex II
conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III II: Up to class IIb only
- *MD 1302 - Monitoring devices of vital physiological EC verification Annex IV
parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II II: Up to class IIb only
therapy conformity (full quality Annex V
- *MD 1401 - Devices utilising ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III II: Up to class IIb only; III, IV:

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

therapy EC verification Annex IV Surgical ultrasoud devices only

- *MD 1402 - Devices utilising non-ionizing radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II II: Up to class IIb only
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive II: Up to class IIb only
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition II: Up to class IIb only
Berlin Cert Prüf- und Zertifizierstelle für 0633
*MD 1100 - General active medical devices EC verification Annex IV
Medizinprodukte GmbH
Dovestraße 6 - *MD 1108 - Active rehabilitation devices and active EC declaration of Annex II
10587 Berlin prostheses conformity (full quality Annex V
Germany
- *MD 1109 - Active devices for patient positioning and assurance system) Annex VI
transport EC declaration of
- *MD 1111 - Software conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1101 - Devices for extra-corporal circulation, quality assurance)

infusion and haemopheresis EC declaration of
- *MD 1102 - Respiratory devices, devices including conformity (product quality
hyperbaric chambers for oxygen therapy, inhalation assurance)
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1112 - Medical gas supply systems and parts
thereof
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0106 - Non-active instruments
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
*MDS 7004 - Medical devices referencing the Directive

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including ethylene oxide gas
sterilisation (EOG), moist heat
sterilisation, radiation sterilisation
(gamma)
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
PRÜFSTELLE FÜR MEDIZINPRODUKTE 0636
*MD 1100 - General active medical devices EC type-examination Annex III
GRAZ
Kopernikusgasse 24/1 - *MD 1101 - Devices for extra-corporal circulation, EC verification Annex IV
8010 GRAZ infusion and haemopheresis EC declaration of Annex II
Austria
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
- *MD 1103 - Devices for stimulation or inhibition conformity (production
- *MD 1104 - Active surgical devices quality assurance)

- *MD 1105 - Active ophthalmologic devices EC declaration of

conformity (product quality
- *MD 1106 - Active dental devices
assurance)
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1202 - Imaging devices utilising non-ionizing

radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7007 - Medical devices utilising micromechanics

NATIONAL EVALUATION CENTER OF 0653
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
QUALITY AND TECHNOLOGY IN HEALTH
S.A.- EKAPTY medical devices conformity (full quality Annex V
Smyrnis 15 - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
165 62 GLYFADA
Greece
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable EC declaration of Annex II

medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices conformity (full quality Annex V

- *MD 0107 - Contraceptive medical devices assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0109 - Non-active devices for in vitro fertilisation assurance system) Annex VI
(IVF) and assisted reproductive technologies (ART) EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex VI
infusion and haemopheresis assurance system)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Respiratory devices only
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex VI
hyperbaric chambers for oxygen therapy, inhalation assurance system)
anaesthesia EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Only for physiotherapy
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Only for physiotherapy
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1404 - Devices for (extracorporal) shock-wave assurance system) Annex VI
therapy (lithotripsy) EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC declaration of Annex II

- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal Only for MD Codes referred above
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive Only for MD Codes referred above
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), moist heat sterilisation, dry
heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam) - Only for MD
Codes referred above
*MDS 7010 - Medical devices incorporating software Only for MD Codes referred above
/utilising software /controlled by software
Eurofins Product Service GmbH 0681
*MD 0100 - General non-active, non-implantable EC type-examination Annex III excluding class III devices (valid for
Storkower Straße 38c
15526 REICHENWALDE medical devices EC verification Annex IV the complete scope)
Germany - *MD 0103 - Non-active orthopaedic and rehabilitation EC declaration of Annex II
devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III excluding class III devices (valid for
- *MD 1108 - Active rehabilitation devices and active EC verification Annex IV the complete scope)
prostheses EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III excluding class III devices (valid for
- *MD 1109 - Active devices for patient positioning and EC verification Annex IV the complete scope)
transport EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

2006/42/EC on machinery
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
THERAPEUTIC GOODS ADMINISTRATION 0805
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
136 Narrabundah Lane
Symonston ACT medical devices conformity (full quality Annex V
Australia - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
- *MD 0102 - Non-active devices for injection, infusion, conformity (production
transfusion and dialysis quality assurance)

- *MD 0103 - Non-active orthopaedic and rehabilitation EC declaration of

devices conformity (product quality
assurance)
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0403 - Dental implants

*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
UL INTERNATIONAL (UK) LTD 0843
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Limited to sterile single use
Wonersh House Building C The Guildway Old
Portsmouth Road medical devices conformity (full quality Annex V devices, class IIb and below
Guildford GU3 1LR - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
United Kingdom
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Limited to sterile single use
medical devices conformity (full quality Annex V devices and surgical instruments,
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
class IIb and below

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

transfusion and dialysis EC declaration of

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Class IIb and below
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Class IIb and below
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Class IIb and below
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Class IIb and below
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Limited to sterile single use
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V devices, class IIb and below
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Class IIb and below
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Class IIb and below
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Class IIb and below
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Class IIb and below
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II No class III or implants
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II No class III or implants
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II No class III or implants
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II No class III or implants
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II No class III or implants
therapy conformity (full quality Annex V
- *MD 1401 - Devices utilising ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II No class III or implants
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II No class III or implants
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II No class III or implants
therapy conformity (full quality Annex V
- *MD 1404 - Devices for (extracorporal) shock-wave assurance system) Annex VI
therapy (lithotripsy) EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Limited to Cardiac catheters
- *MD 0201 - Non-active cardiovascular implants conformity (full quality
assurance system)
*MD 1100 - General active medical devices EC declaration of Annex II No class III or implants
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III or implants
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III or implants
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III or implants
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III or implants
- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III or implants
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III or implants
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III or implants
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III or implants
- *MD 1109 - Active devices for patient positioning and conformity (full quality Annex V
transport assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III or implants
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam and
formaldehyde sterilisation, moist
heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam), others (need to be

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

specified)
Országos Gógyszerészeti és 1011
*MD 1200 - Devices for imaging EC declaration of Annex II
Élelmezés-egészségügyi Intézet
Eszközmin#sít# és Kórháztechnikai - *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
Igazgatóság (National Institute of Pharmacy radiation assurance system)
and Nutrition)
Zrínyi u. 3
EC declaration of
H-1051 Budapest conformity (production
Hungary quality assurance)
*MD 1200 - Devices for imaging EC type-examination Annex III
- *MD 1202 - Imaging devices utilising non-ionizing EC declaration of Annex II
radiation conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III
- *MD 1301 - Monitoring devices of non-vital EC declaration of Annex II
physiological parameters conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1302 - Monitoring devices of vital physiological EC declaration of Annex II

parameters conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III
therapy EC declaration of Annex II
- *MD 1402 - Devices utilising non-ionizing radiation conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III
therapy EC declaration of Annex II
- *MD 1403 - Devices for hyperthermia / hypothermia conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC declaration of Annex II
- *MD 0101 - Non-active devices for anaesthesia, conformity (full quality Annex V
emergency and intensive care assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC declaration of Annex II
- *MD 0102 - Non-active devices for injection, infusion, conformity (full quality Annex V
transfusion and dialysis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC declaration of Annex II
- *MD 0103 - Non-active orthopaedic and rehabilitation conformity (full quality Annex V
devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC declaration of Annex II
- *MD 0104 - Non-active medical devices with conformity (full quality Annex V
measuring function assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC declaration of Annex II
- *MD 0106 - Non-active instruments conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC declaration of Annex II
- *MD 0107 - Contraceptive medical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Annex III. designation excluding
medical devices EC declaration of Annex II materials of desinfecting, cleaning
- *MD 0108 - Non-active medical devices for conformity (full quality and rinsing . For Annex II., V., VI.
Annex V
disinfecting, cleaning, rinsing assurance system) there are no limitations.
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
medical devices EC declaration of Annex II
- *MD 0109 - Non-active devices for in vitro fertilisation conformity (full quality Annex V
(IVF) and assisted reproductive technologies (ART) assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC type-examination Annex III
- *MD 0401 - Non-active dental equipment and EC declaration of Annex II
instruments conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC type-examination Annex III
- *MD 0403 - Dental implants EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1101 - Devices for extra-corporal circulation, EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

infusion and haemopheresis conformity (full quality Annex V

assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1102 - Respiratory devices, devices including EC declaration of Annex II
hyperbaric chambers for oxygen therapy, inhalation conformity (full quality Annex V
anaesthesia assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1103 - Devices for stimulation or inhibition EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC type-examination Annex III

- *MD 1104 - Active surgical devices EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1110 - Active devices for in vitro fertilisation EC declaration of Annex II
(IVF) and assisted reproductive therapy (ART) conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1111 - Software EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1112 - Medical gas supply systems and parts EC declaration of Annex II
thereof conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1106 - Active dental devices EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1107 - Active devices for disinfection and EC declaration of Annex II
sterilisation conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1108 - Active rehabilitation devices and active EC declaration of Annex II
prostheses conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1109 - Active devices for patient positioning and EC declaration of Annex II
transport conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC type-examination Annex III
- *MD 0202 - Non-active orthopaedic implants EC declaration of Annex II
conformity (full quality Annex V
assurance system)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC type-examination Annex III
- *MD 0203 - Non-active functional implants EC declaration of Annex II
conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Excluding breast and body shaping
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V implants
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC type-examination Annex III
- *MD 0301 - Bandages and wound dressings EC declaration of Annex II
conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC type-examination Annex III
- *MD 0302 - Suture material and clamps EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal Designation excludes products
origin, including Regulation 722/2012 (Directive related 2003/32/EC BSE/TSE field.
2003/32/EC up to 28.08.2013) Designation includes Annex 2 and
5.
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam and

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

formaldehyde sterilisation, moist

heat sterilisation
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, 1014
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
s.p.
Pod Lisem 129 medical devices system Annex V
171 02 PRAHA 71 - Troja - *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
Czech Republic
emergency and intensive care assurance
- *MD 0102 - Non-active devices for injection, infusion, Product quality assurance
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0300 - Devices for wound care

- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1101 - Devices for extra-corporal circulation, system Annex III
infusion and haemopheresis EC type-examination Annex IV
- *MD 1102 - Respiratory devices, devices including EC verification Annex V
hyperbaric chambers for oxygen therapy, inhalation Production quality Annex VI
anaesthesia assurance
- *MD 1103 - Devices for stimulation or inhibition Product quality assurance
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1200 - Devices for imaging

- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1112 - Medical gas supply systems and parts EC verification Annex IV
thereof EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam and
formaldehyde sterilisation, moist
heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam), others (need to be
specified)
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
INSTITUT PRO TESTOVÁNI A CERTIFIKACI, 1023
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Limited to devices of Classes Im,
a. s.
T. Bati 299 medical devices conformity (full quality Annex V Is, IIa, IIb plus epidural sets
Louky, 76302 ZLIN - *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
Czech Republic
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Limited to devices of Classes Im,

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices conformity (full quality Annex V Is, IIa, IIb plus balloon catheters
- *MD 0101 - Non-active devices for anaesthesia, assurance system) Annex VI plus stent delivery systems
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Limited to devices of Classes Im,
medical devices conformity (full quality Annex V Is, IIa, IIb
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Limited to devices of Classes Im,
medical devices conformity (full quality Annex V Is, IIa, IIb
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Limited to devices of Classes Im,
medical devices conformity (full quality Annex V Is, IIa, IIb

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0106 - Non-active instruments assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Limited to devices of Classes Im,
medical devices conformity (full quality Annex V Is, IIa, IIb
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Limited to cardiovascular stents
- *MD 0201 - Non-active cardiovascular implants conformity (full quality Annex V including stent inserting tools plus
assurance system) cardiac valves not containing
Annex VI
EC declaration of animal tissues
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Limited to devices of the Class IIb
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Limited to devices of the Class IIb
- *MD 0203 - Non-active functional implants conformity (full quality Annex V oesophageal, ureteral and biliary
assurance system) stents
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II Limited to devices of the Class IIb
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V plus injection implants based on
assurance system) hyaluronic acid and hyaluronic acid
Annex VI
EC declaration of derivates
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Limited to devices of Classes Is,
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V IIa, IIb plus wound dressing being
assurance system) wholly or mainly absorbed and/or
Annex VI
EC declaration of incorporating medicinal substances

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Limited to devices of Classes Is,
- *MD 0302 - Suture material and clamps conformity (full quality Annex V IIa, IIb plus devices being wholly or
assurance system) mainly absorbed plus sutures for
Annex VI
EC declaration of the central circulatory system
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Limited to devices of Classes Is,
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V IIa, IIb plus wound care devices
assurance system) being wholly or mainly absorbed
Annex VI
EC declaration of and/or incorporating medicinal
conformity (production substances
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Limited to devices of Classes Im,
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V Is, IIa, IIb
instruments assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Limited to devices of Classes Is,
- *MD 0402 - Dental materials conformity (full quality Annex V IIa, IIb
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Limited to devices of Classes IIa,
- *MD 0403 - Dental implants conformity (full quality Annex V IIb
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Limited to devices of Classes Im,
- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V Is, IIa, IIb
infusion and haemopheresis assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Limited to devices of Classes Im,
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V Is, IIa, IIb
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Limited to devices of Classes Im,
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V Is, IIa, IIb
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Limited to devices of Classes Im,
- *MD 1104 - Active surgical devices conformity (full quality Annex V Is, IIa, IIb
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Limited to devices of Classes Im,
- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V Is, IIa, IIb
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Limited to devices of Classes Im,
- *MD 1106 - Active dental devices conformity (full quality Annex V Is, IIa, IIb
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Limited to devices of Classes Im,
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V Is, IIa, IIb
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Limited to devices of Classes Im,
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V Is, IIa, IIb
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Limited to devices of Classes Im,
- *MD 1111 - Software conformity (full quality Annex V IIa, IIb
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Limited to devices of Classes Im,
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V Is, IIa, IIb
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1200 - Devices for imaging EC declaration of Annex II Limited to devices of Classes Im,
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V Is, IIa, IIb
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Limited to devices of Classes Im,
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V Is, IIa, IIb
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Limited to devices of Classes Im,
therapy conformity (full quality Annex V Is, IIa, IIb
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Limited to devices of Classes Im,

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

therapy conformity (full quality Annex V Is, IIa, IIb

- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7006 - Medical devices in sterile condition Limited to devices sterilised by one
of the following: Aseptic filling,
Ethylene oxide sterilisation,
Radiation sterilisation, Moist heat
sterilisation
*MDS 7009 - Medical devices utilising biological active Limited to devices being wholly or
coatings and/or materials or being wholly or mainly mainly absorbed
absorbed
*MDS 7010 - Medical devices incorporating software Limited to devices of Classes Im,
/utilising software /controlled by software Is, IIa, IIb
Schweizerische Vereinigung für Qualitäts- und 1250
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
Managementsysteme
Bernstrasse 103 medical devices system Annex V
3052 Zollikofen - *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
Switzerland
transfusion and dialysis assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation Production quality Annex VI
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

devices assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0104 - Non-active medical devices with Production quality Annex VI
measuring function assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0105 - Non-active ophthalmologic devices Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0106 - Non-active instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0108 - Non-active medical devices for Production quality Annex VI
disinfecting, cleaning, rinsing assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
Product quality assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0200 - Non-active implants Full quality assurance Annex II

- *MD 0202 - Non-active orthopaedic implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0203 - Non-active functional implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0204 - Non-active soft tissue implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0301 - Bandages and wound dressings system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0302 - Suture material and clamps system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0303 - Other medical devices for wound care system Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

Production quality Annex VI

assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0401 - Non-active dental equipment and system Annex V
instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0402 - Dental materials system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0403 - Dental implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II excluding heart-lung machine
- *MD 1101 - Devices for extra-corporal circulation, system Annex V
infusion and haemopheresis Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II only respiratory devices
- *MD 1102 - Respiratory devices, devices including system Annex V
hyperbaric chambers for oxygen therapy, inhalation Production quality Annex VI
anaesthesia assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

Product quality assurance

*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1103 - Devices for stimulation or inhibition system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1104 - Active surgical devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1105 - Active ophthalmologic devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1106 - Active dental devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1107 - Active devices for disinfection and system Annex V
sterilisation Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1108 - Active rehabilitation devices and active system Annex V

prostheses Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1201 - Imaging devices utilising ionizing system Annex V
radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1202 - Imaging devices utilising non-ionizing system Annex V
radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1404 - Devices for (extracorporal) shock-wave Production quality Annex VI
therapy (lithotripsy) assurance
Product quality assurance
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
QS Zürich AG 1254
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II Single-use medical devices
Postfach 6335
CH-8050 Zürich medical devices system Annex V
Switzerland - *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
Product quality assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable Full quality assurance Annex II Single-use medical devices
medical devices system Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
transfusion and dialysis assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation Production quality Annex VI
devices assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II Reusable instruments
medical devices system Annex V
- *MD 0104 - Non-active medical devices with Production quality Annex VI
measuring function assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II Single-use medical devices
medical devices system Annex V
- *MD 0105 - Non-active ophthalmologic devices Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0106 - Non-active instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II Single-use medical devices
medical devices system Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0107 - Contraceptive medical devices Production quality Annex VI

assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II Single-use medical devices
medical devices system Annex V
- *MD 0108 - Non-active medical devices for Production quality Annex VI
disinfecting, cleaning, rinsing assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0202 - Non-active orthopaedic implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0203 - Non-active functional implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0301 - Bandages and wound dressings system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0302 - Suture material and clamps system Annex V
Production quality Annex VI
assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

Product quality assurance

*MD 0300 - Devices for wound care Full quality assurance Annex II
- *MD 0303 - Other medical devices for wound care system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0401 - Non-active dental equipment and system Annex V
instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0402 - Dental materials system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories Full quality assurance Annex II
- *MD 0403 - Dental implants system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1106 - Active dental devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1109 - Active devices for patient positioning and system Annex V
transport Production quality Annex VI
assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1202 - Imaging devices utilising non-ionizing system Annex V
radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1300 - Monitoring devices Full quality assurance Annex II
- *MD 1301 - Monitoring devices of non-vital system Annex V
physiological parameters Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7006 - Medical devices in sterile condition Including aseptic processing,

ethylene oxide gas sterilisation
(EOG), low temperature steam and
formaldehyde sterilisation, moist
heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam)
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
ENTE CERTIFICAZIONE MACCHINE SRL 1282
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III devices
Via Ca’ Bella, 243/A - loc. Castello di Serravalle
40053 Valsamoggia (BO) medical devices conformity (full quality Annex V
Italy - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III devices
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III devices
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III devices
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III devices
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
infusion and haemopheresis assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III devices
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III devices
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III devices
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

sterilisation assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III devices
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III devices
- *MD 1109 - Active devices for patient positioning and conformity (full quality Annex V
transport assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III devices
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III devices
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III devices
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III devices
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
SLOVENIAN INSTITUTE OF QUALITY AND 1304
*MD 1100 - General active medical devices EC type-examination Annex III Annex III and IV lasers only
METROLOGY - SIQ
Trzaska cesta 2 - *MD 1105 - Active ophthalmologic devices EC verification Annex IV
1000 LJUBLJANA
EC declaration of Annex II
Slovenia
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II Only infant incubators included
- *MD 1101 - Devices for extra-corporal circulation, system Annex V
infusion and haemopheresis Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices EC declaration of Annex II Included only devices for

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V respiratory devices
hyperbaric chambers for oxygen therapy, inhalation assurance system) Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1103 - Devices for stimulation or inhibition EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1104 - Active surgical devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices EC type-examination Annex III Annex III and IV lasers only
- *MD 1106 - Active dental devices EC verification Annex IV
EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (full quality Annex V

assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1107 - Active devices for disinfection and system Annex V
sterilisation Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1109 - Active devices for patient positioning and conformity (full quality Annex V
transport assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III
- *MD 1301 - Monitoring devices of non-vital EC verification Annex IV
physiological parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III
- *MD 1302 - Monitoring devices of vital physiological EC verification Annex IV
parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC type-examination Annex III
- *MD 1202 - Imaging devices utilising non-ionizing EC verification Annex IV
radiation EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0107 - Contraceptive medical devices assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II Included only devices for injection,
medical devices system Annex V infusion and transfusion
- *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
transfusion and dialysis assurance
Product quality assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable Full quality assurance Annex II

medical devices system Annex V
- *MD 0104 - Non-active medical devices with Production quality Annex VI
measuring function assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0105 - Non-active ophthalmologic devices Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0106 - Non-active instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II
therapy conformity (full quality Annex V
- *MD 1402 - Devices utilising non-ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system)
EC declaration of
conformity (production
quality assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Excluding formaldehyde
sterilisation
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
BUREAU VERITAS ITALIA S.P.A. 1370
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
Via Miramare, 15
20126 - MILANO medical devices conformity (full quality Annex V
Italy - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III medical devices
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III medical devices
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III medical devices
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices,
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V hyperbaric chambers for oxygen
hyperbaric chambers for oxygen therapy, inhalation assurance system) therapy and medical gas pipeline
Annex VI
anaesthesia EC declaration of systems
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1106 - Active dental devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (product quality

assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III medical devices
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III medical devices
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III medical devices
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V
parameters assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III medical devices
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7004 - Medical devices referencing the Directive Excluding class III medical devices
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Excluding class III medical devices
POLSKIE CENTRUM BADAN I 1434
*MD 0100 - General non-active, non-implantable EC type-examination Annex III
CERTYFIKACJI S.A.
ul. Klobucka 23A medical devices EC verification Annex IV
02-699 Warszawa - *MD 0102 - Non-active devices for injection, infusion, EC declaration of Annex II
Poland
transfusion and dialysis conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
- *MD 0105 - Non-active ophthalmologic devices conformity (production
- *MD 0106 - Non-active instruments quality assurance)

- *MD 0107 - Contraceptive medical devices EC declaration of

conformity (product quality
- *MD 0101 - Non-active devices for anaesthesia,
assurance)
emergency and intensive care
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0110 - Non-active medical devices for ingestion
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0302 - Suture material and clamps

- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
- *MD 1112 - Medical gas supply systems and parts
thereof
*MD 1200 - Devices for imaging
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1201 - Imaging devices utilising ionizing

radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7009 - Medical devices utilising biological active

coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
SGS Belgium NV 1639
*MD 0100 - General non-active, non-implantable EC declaration of Annex II No class III medical devices.
Noorderlaan 87
BE-2030 Antwerpen medical devices conformity (full quality Annex V
Belgium - *MD 0101 - Non-active devices for anaesthesia, assurance system)
emergency and intensive care EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II No class III medical devices.
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system)
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II No class III medical devices.
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system)
devices EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II No class III medical devices.
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
measuring function EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II No class III medical devices.
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II No class III medical devices.
medical devices conformity (full quality Annex V Limited to accessories (e.g.
- *MD 0107 - Contraceptive medical devices assurance system) lubricants etc) and male/female
EC declaration of condoms. No diaphragm's or IUD's
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II No class III medical devices.
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II No class III medical devices.
medical devices conformity (full quality Annex V Limited to devices such as
- *MD 0109 - Non-active devices for in vitro fertilisation assurance system) receptacles, petri dishes, pipettes
(IVF) and assisted reproductive technologies (ART) EC declaration of or syringes. No media, substances
conformity (production or mixture of substances.
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II No class III medical devices. No
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V joints (partial or complete).
assurance system)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II No class III medical devices.
- *MD 0203 - Non-active functional implants conformity (full quality Annex V Limited to implantable holders
assurance system) used in radiotherapy
EC declaration of (brachytherapy) and class IIb
conformity (production spinal Implants, spinal stents and
quality assurance) cervical cage.

*MD 0300 - Devices for wound care EC declaration of Annex II No class III medical devices.
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II No class III medical devices.
- *MD 0302 - Suture material and clamps conformity (full quality Annex V Limited to clamps and staples.
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II No class III medical devices.
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II No class III medical devices.

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II No class III medical devices.
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II No class III medical devices.
- *MD 0403 - Dental implants conformity (full quality Annex V Limited to crowns, prostheses and
assurance system) bridges.
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III medical devices. Only
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V parts (e.g. connectors, flow meters,
thereof assurance system) Venturi, plastic tubing,…). No
EC declaration of complete gas supply systems. No
conformity (production medical glasses.
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III medical devices.
- *MD 1103 - Devices for stimulation or inhibition conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III medical devices.
- *MD 1104 - Active surgical devices conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III medical devices.
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V
sterilisation assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III medical devices.
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III medical devices.
- *MD 1109 - Active devices for patient positioning and conformity (full quality Annex V
transport assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II No class III medical devices.
- *MD 1111 - Software conformity (full quality Annex V
assurance system)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II No class III medical devices.
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
radiation assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II No class III medical devices.
- *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V
radiation assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II No class III medical devices.
- *MD 1301 - Monitoring devices of non-vital conformity (full quality Annex V
physiological parameters assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1300 - Monitoring devices EC declaration of Annex II No class III medical devices. No
- *MD 1302 - Monitoring devices of vital physiological conformity (full quality Annex V devices intended for the monitoring
parameters assurance system) of vital physiological parameters,
EC declaration of where the nature of variations is
conformity (production such that it could result in
quality assurance) immediate danger to the patient.

*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II No class III medical devices.

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

therapy conformity (full quality Annex V

- *MD 1401 - Devices utilising ionizing radiation assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II No class III medical devices.
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system)
EC declaration of
conformity (production
quality assurance)
*MDS 7004 - Medical devices referencing the Directive No class III medical devices.
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition No class III medical devices. For
ETO, irradiation, moist heat,
aseptic process and clean rooms
technologies
*MDS 7010 - Medical devices incorporating software No class III medical devices.
/utilising software /controlled by software
TURKISH STANDARDS INSTITUTION (TSE) 1783
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
Necatibey Cad. No. 112, 06100 Bakanliklar
Ankara medical devices conformity (full quality Annex V
Turkey - *MD 0101 - Non-active devices for anaesthesia, assurance system)
emergency and intensive care EC declaration of
- *MD 0102 - Non-active devices for injection, infusion, conformity (production
transfusion and dialysis quality assurance)

- *MD 0103 - Non-active orthopaedic and rehabilitation

devices
- *MD 0104 - Non-active medical devices with

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

measuring function
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)

- *MD 0107 - Contraceptive medical devices EC declaration of

conformity (production
- *MD 0108 - Non-active medical devices for
quality assurance)
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0400 - Non-active dental devices and accessories

- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1202 - Imaging devices utilising non-ionizing

radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MDS 7010 - Medical devices incorporating software

/utilising software /controlled by software
DARE!! Certifications 1912
*MD 1100 - General active medical devices EC type-examination Annex III Limited to devices for infusion.
Vijzelmolenlaan 7
NL-3447 GX Woerden - *MD 1101 - Devices for extra-corporal circulation, EC verification Annex IV Limited to non sterile class Im, IIa
Netherlands infusion and haemopheresis and IIb devices

*MD 1100 - General active medical devices EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1102 - Respiratory devices, devices including EC verification Annex IV and IIb devices
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
*MD 1100 - General active medical devices EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1103 - Devices for stimulation or inhibition EC verification Annex IV and IIb devices

*MD 1100 - General active medical devices EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1104 - Active surgical devices EC verification Annex IV and IIb devices

*MD 1100 - General active medical devices EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1108 - Active rehabilitation devices and active EC verification Annex IV and IIb devices
prostheses
*MD 1100 - General active medical devices EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1109 - Active devices for patient positioning and EC verification Annex IV and IIb devices
transport
*MD 1200 - Devices for imaging EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1202 - Imaging devices utilising non-ionizing EC verification Annex IV and IIb devices
radiation
*MD 1300 - Monitoring devices EC type-examination Annex III Limited to non sterile class Im, IIa
- *MD 1301 - Monitoring devices of non-vital EC verification Annex IV and IIb devices
physiological parameters
*MD 1300 - Monitoring devices EC type-examination Annex III Limited to non sterile class Im, IIa

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1302 - Monitoring devices of vital physiological EC verification Annex IV and IIb devices
parameters
*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III Limited to non sterile class Im, IIa
therapy EC verification Annex IV and IIb devices
- *MD 1402 - Devices utilising non-ionizing radiation
*MDS 7004 - Medical devices referencing the Directive Limited to non sterile class Im, IIa
2006/42/EC on machinery and IIb devices
*MDS 7010 - Medical devices incorporating software Limited to non sterile class Im, IIa
/utilising software /controlled by software and IIb devices
TUV Rheinland Italia SRL 1936
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
Via Mattei, 3
20010 - Pogliano Milanese (MI) medical devices conformity (full quality Annex V
Italy - *MD 0101 - Non-active devices for anaesthesia, assurance system)
Annex VI
emergency and intensive care EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system) Annex VI
transfusion and dialysis EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

medical devices conformity (full quality Annex V

- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system) Annex VI
devices EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
Annex VI
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0105 - Non-active ophthalmologic devices assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0106 - Non-active instruments assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III medical devices
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III medical devices
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0402 - Dental materials conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Excluding class III medical devices
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III medical devices
- *MD 1101 - Devices for extra-corporal circulation, EC verification Annex IV
infusion and haemopheresis EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III medical devices
- *MD 1108 - Active rehabilitation devices and active EC verification Annex IV
prostheses EC declaration of Annex II

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (full quality Annex V

assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III medical devices
- *MD 1109 - Active devices for patient positioning and EC verification Annex IV
transport EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III medical devices
- *MD 1102 - Respiratory devices, devices including EC verification Annex IV and hyperbaric chambers for
hyperbaric chambers for oxygen therapy, inhalation oxygen therapy
EC declaration of Annex II
anaesthesia conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1103 - Devices for stimulation or inhibition EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III
- *MD 1104 - Active surgical devices EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1105 - Active ophthalmologic devices conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC type-examination Annex III Excluding class III medical devices
- *MD 1106 - Active dental devices EC verification Annex IV
EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

sterilisation assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging EC declaration of Annex II Excluding class III medical devices
- *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III Excluding class III medical devices
- *MD 1301 - Monitoring devices of non-vital EC verification Annex IV
physiological parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices EC type-examination Annex III

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1302 - Monitoring devices of vital physiological EC verification Annex IV

parameters EC declaration of Annex II
conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III medical devices
therapy conformity (full quality Annex V
- *MD 1401 - Devices utilising ionizing radiation assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo EC verification Annex IV Excluding class III medical devices
therapy EC declaration of Annex II
- *MD 1402 - Devices utilising non-ionizing radiation conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance)
*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding class III medical devices
therapy conformity (full quality Annex V
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0200 - Non-active implants EC declaration of Annex II Excluding class III medical devices
- *MD 0204 - Non-active soft tissue implants conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam
sterilisation, moist heat
sterilisation, radiation sterilisation
(gamma, x-ray, electron beam)
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
Kiwa Belgelendirme Hizmetleri A.#. 1984
*MD 1200 - Devices for imaging EC declaration of Annex II
Tepeören Mevkii Ankara Asfalt# Maret Arkas#
ITOSB 9. Cadde No: 15 Tuzla - *MD 1201 - Imaging devices utilising ionizing conformity (full quality Annex V
Istanbul radiation assurance system)
Turkey
- *MD 1202 - Imaging devices utilising non-ionizing EC declaration of
radiation conformity (production
quality assurance)
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0106 - Non-active instruments

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0108 - Non-active medical devices for

disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0107 - Contraceptive medical devices
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1111 - Software

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1102 - Respiratory devices, devices including

hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1108 - Active rehabilitation devices and active
prostheses
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0110 - Non-active medical devices for ingestion
*MD 1100 - General active medical devices
- *MD 1112 - Medical gas supply systems and parts
thereof
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

amended by Directive 2001/104/EC

*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
Szutest Uygunluk De#erlendirme A.#. 2195
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
Yukar# Dudullu Mahallesi Nato Yolu Caddesi
Çam Sokak No: 7 Ümraniye medical devices system Annex V
#STANBUL - *MD 0101 - Non-active devices for anaesthesia, Production quality
Turkey
emergency and intensive care assurance
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0107 - Contraceptive medical devices assurance system)

EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants Full quality assurance Annex II
- *MD 0202 - Non-active orthopaedic implants system Annex V
- *MD 0203 - Non-active functional implants Production quality
assurance
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1106 - Active dental devices

- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)

- *MD 1112 - Medical gas supply systems and parts EC declaration of

thereof conformity (production
quality assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
3EC International a.s. 2265
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
3EC International a.s. Hranicna 18 Bratislava
82105 SLOVAKIA medical devices conformity (full quality Annex V
Bratislava 82105 - *MD 0110 - Non-active medical devices for ingestion assurance system) Annex VI
Slovakia
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
- *MD 0102 - Non-active devices for injection, infusion, Product quality assurance
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0106 - Non-active instruments

- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1103 - Devices for stimulation or inhibition

- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1403 - Devices for hyperthermia / hypothermia

- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal excluding Regulation 722/2012
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
TUV NORD Polska Sp. z o.o 2274
*MD 1100 - General active medical devices Full quality assurance Annex II .
ul. Mickiewicza 29
40-085 Katowice - *MD 1101 - Devices for extra-corporal circulation, system Annex V
Poland infusion and haemopheresis Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1103 - Devices for stimulation or inhibition system Annex V
Production quality Annex VI
assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

Product quality assurance

*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1104 - Active surgical devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1106 - Active dental devices system Annex V
Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices Full quality assurance Annex II
- *MD 1109 - Active devices for patient positioning and system Annex V
transport Production quality Annex VI
assurance
Product quality assurance
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

sterilisation assurance system) Annex VI

EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1102 - Respiratory devices, devices including conformity (full quality Annex V
hyperbaric chambers for oxygen therapy, inhalation assurance system)
Annex VI
anaesthesia EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices EC declaration of Annex II without acitive prostheses
- *MD 1108 - Active rehabilitation devices and active conformity (full quality Annex V
prostheses assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1201 - Imaging devices utilising ionizing system Annex V
radiation Production quality Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance
Product quality assurance
*MD 1200 - Devices for imaging Full quality assurance Annex II
- *MD 1202 - Imaging devices utilising non-ionizing system Annex V
radiation Production quality Annex VI
assurance
Product quality assurance
*MD 1300 - Monitoring devices Full quality assurance Annex II
- *MD 1301 - Monitoring devices of non-vital system Annex V
physiological parameters Production quality Annex VI
assurance
Product quality assurance
*MD 1300 - Monitoring devices Full quality assurance Annex II
- *MD 1302 - Monitoring devices of vital physiological system Annex V
parameters Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0102 - Non-active devices for injection, infusion, Production quality Annex VI
transfusion and dialysis assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation Production quality Annex VI
devices assurance
Product quality assurance

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable Full quality assurance Annex II

medical devices system Annex V
- *MD 0104 - Non-active medical devices with Production quality Annex VI
measuring function assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0106 - Non-active instruments Production quality Annex VI
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
medical devices system Annex V
- *MD 0101 - Non-active devices for anaesthesia, Production quality Annex VI
emergency and intensive care assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
Annex VI
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1401 - Devices utilising ionizing radiation Production quality Annex VI

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II
therapy system Annex V
- *MD 1402 - Devices utilising non-ionizing radiation Production quality Annex VI
assurance
Product quality assurance
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality
assurance system)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1100 - General active medical devices EC declaration of Annex II

- *MD 1112 - Medical gas supply systems and parts conformity (full quality Annex V
thereof assurance system)
Annex VI
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality
assurance system)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0403 - Dental implants conformity (full quality
assurance system)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7006 - Medical devices in sterile condition
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
DQS Polska Sp. z o.o 2282
*MD 1100 - General active medical devices EC declaration of Annex II
ul. Post#pu 17A
02-676 Warszawa - *MD 1101 - Devices for extra-corporal circulation, conformity (full quality Annex V
Poland infusion and haemopheresis assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1107 - Active devices for disinfection and conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

sterilisation assurance system)

EC declaration of
conformity (production
quality assurance)
*MD 1100 - General active medical devices EC declaration of Annex II
- *MD 1111 - Software conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0103 - Non-active orthopaedic and rehabilitation assurance system)
devices EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0104 - Non-active medical devices with assurance system)
measuring function EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II excluding dialysers
medical devices conformity (full quality Annex V
- *MD 0102 - Non-active devices for injection, infusion, assurance system)
transfusion and dialysis EC declaration of
conformity (production
quality assurance)

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 0100 - General non-active, non-implantable EC declaration of Annex II

medical devices conformity (full quality Annex V
- *MD 0106 - Non-active instruments assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0107 - Contraceptive medical devices assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0108 - Non-active medical devices for assurance system)
disinfecting, cleaning, rinsing EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
medical devices conformity (full quality Annex V
- *MD 0110 - Non-active medical devices for ingestion assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants EC declaration of Annex II
- *MD 0202 - Non-active orthopaedic implants conformity (full quality Annex V
assurance system)
EC declaration of

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0302 - Suture material and clamps conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0300 - Devices for wound care EC declaration of Annex II
- *MD 0303 - Other medical devices for wound care conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0401 - Non-active dental equipment and conformity (full quality Annex V
instruments assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0402 - Dental materials conformity (full quality Annex V

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
EC declaration of
conformity (production
quality assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
UDEM Uluslararasi Belgelendirme Denetim 2292
*MD 0300 - Devices for wound care EC declaration of Annex II
Egitim Merkezi San. ve Tic. A.#.
Mutlukent Mahallesi 2073 Sokak No:10 - *MD 0301 - Bandages and wound dressings conformity (full quality Annex V
Umitkoy-CANKAYA assurance system)
- *MD 0302 - Suture material and clamps
Ankara

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives
Turkey
- *MD 0303 - Other medical devices for wound care EC declaration of
*MD 0100 - General non-active, non-implantable conformity (production
medical devices quality assurance)

- *MD 0101 - Non-active devices for anaesthesia,

emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
- *MD 0110 - Non-active medical devices for ingestion
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0402 - Dental materials

- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
- *MD 1112 - Medical gas supply systems and parts
thereof
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1403 - Devices for hyperthermia / hypothermia

- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam and
formaldehyde sterilisation, moist
heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam), others (need to be
specified)
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
CE Certiso Orvos- és Kórháztechnikai 2409
*MD 1200 - Devices for imaging EC declaration of Annex II
Ellen#rz# és Tanúsító Kft.
Gyár u. 2. - *MD 1202 - Imaging devices utilising non-ionizing conformity (full quality Annex V
Budaörs radiation assurance system)
Annex VI
Hungary
*MD 1300 - Monitoring devices EC declaration of
conformity (production
- *MD 1301 - Monitoring devices of non-vital
quality assurance)
physiological parameters
EC declaration of
- *MD 1302 - Monitoring devices of vital physiological
conformity (product quality
parameters

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Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

*MD 1400 - Devices for radiation therapy and thermo assurance)

therapy
- *MD 1402 - Devices utilising non-ionizing radiation
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
- *MD 0110 - Non-active medical devices for ingestion
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 0301 - Bandages and wound dressings

- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1111 - Software
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
*MDS 7001 - Medical devices incorporating medicinal regarding Annex II, V, VI
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive regarding Annex II, V, VI

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition regarding Annex II, V, VI Including
aseptic processing, ethylene oxide
gas sterilisation (EOG), radiation
sterilization (gamma,x-ray, electron
beam), moist heat sterilization
*MDS 7009 - Medical devices utilising biological active regarding Annex II, V, VI
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software regarding Annex II, V, VI
/utilising software /controlled by software
DNV GL Nemko Presafe AS 2460
*MD 0100 - General non-active, non-implantable EC declaration of Annex II
Veritasveien 3
1363 Høvik medical devices conformity (full quality Annex V
Norway - *MD 0101 - Non-active devices for anaesthesia, assurance system)
emergency and intensive care EC declaration of
- *MD 0102 - Non-active devices for injection, infusion, conformity (production
transfusion and dialysis quality assurance)

- *MD 0103 - Non-active orthopaedic and rehabilitation

devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation

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Creation Date : 18/01/2018

LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

(IVF) and assisted reproductive technologies (ART)

*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories EC verification Annex IV
- *MD 0401 - Non-active dental equipment and EC declaration of Annex II
instruments conformity (full quality Annex V
- *MD 0402 - Dental materials assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II
- *MD 0403 - Dental implants conformity (full quality Annex V
assurance system)
*MD 1100 - General active medical devices
EC declaration of
- *MD 1101 - Devices for extra-corporal circulation,
conformity (production
infusion and haemopheresis
quality assurance)
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition

342 / 344
Creation Date : 18/01/2018

LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1104 - Active surgical devices

- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
- *MD 1112 - Medical gas supply systems and parts
thereof
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation

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Creation Date : 18/01/2018

LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notified ID Responsible for the following products Responsible for the Annexes or Limitations (English only)
bodies /Horizontal technical competence following procedures articles of the
or modules directives

- *MD 1402 - Devices utilising non-ionizing radiation

- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam and
formaldehyde sterilisation, moist
heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam), others.
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software

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