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Dixion Vertrieb Medizinischer Geräte GMBH Couvenstr. 6 40211 Düsseldorf Germany

mdc medical device certification GmbH certifies that Dixion Vertrieb medizinischer Geräte GmbH has introduced and applies a quality system for the design, manufacture and final inspection of various medical devices. The audit confirmed the quality system meets the requirements of the European Medical Device Directive. The certification is valid from 2020-04-06 to 2024-05-26 and includes devices like ventilators, patient monitors, and infusion pumps.

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Arbjan Rusi
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412 views3 pages

Dixion Vertrieb Medizinischer Geräte GMBH Couvenstr. 6 40211 Düsseldorf Germany

mdc medical device certification GmbH certifies that Dixion Vertrieb medizinischer Geräte GmbH has introduced and applies a quality system for the design, manufacture and final inspection of various medical devices. The audit confirmed the quality system meets the requirements of the European Medical Device Directive. The certification is valid from 2020-04-06 to 2024-05-26 and includes devices like ventilators, patient monitors, and infusion pumps.

Uploaded by

Arbjan Rusi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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mdc medical device certification GmbH

Notified Body 0483


herewith certifies that

Dixion Vertrieb medizinischer Geräte GmbH


Couvenstr. 6
40211 Düsseldorf
Germany
for the scope
electrocardiographs, patient monitors, modular patient monitors, fetal monitors,
ventilators, anesthesia machines, medical air compressors, medical suction units,
phototherapy lamps, infant incubators, open radiant infant warmer, syringe pumps,
infusion pumps, pulse oximeter, central monitoring station software
(see attachment)
has introduced and applies a

Quality System
for the design, manufacture and final inspection.

The mdc audit has proven that this quality system


meets all requirements according to

Annex II – excluding Section 4


of the Council Directive 93/42/EEC
of 14 June 1993 concerning medical devices.

The surveillance will be held as specified in Annex II, Section 5.

Valid from 2020-04-06


Valid until 2024-05-26
Registration no. D1251600049
Report no. P19-00655-173908
Stuttgart 2020-04-06

Head of Certification Body

mdc medical device certification GmbH


Kriegerstraße 6
D-70191 Stuttgart, Germany
Phone: +49-(0)711-253597-0
Fax: +49-(0)711-253597-10
Internet: http://www.mdc-ce.de For electronic publication only
Attachment of the certificate

No. D1251600049 Date 2020-04-06 Page 1 of 2

Product category Product Class Product code


anesthesia machines Practice 3000 IIa 10-134
Practice 3100
Practice 3200
Practice 3700
Practice 3800
electrocardiographs ECG 1003 IIa 11-411
ECG 1003p.
ECG 1012
ECG 1012Exp.
ECG 1018
patient monitors Storm 5300 IIb 12-636
Storm 5500
Storm 5600
Storm 5800
Storm 5900
Storm 5110
Storm 5120
Storm 5500A
Storm 5500B
Storm 5600A
Storm 5600B
modular patient monitors Storm D2 IIb 12-636
Storm D3
Storm D5
Storm D8
Storm DS3
Storm DS5
Storm DS7
fetal monitors Overtone 6200 IIb 12-610
Overtone 6900
Overtone 6900 lite
Overtone 6900 Exp.

Head of Certification Body

mdc medical device certification GmbH


Kriegerstraße 6
D-70191 Stuttgart, Germany
Phone: +49-(0)711-253597-0
Fax: +49-(0)711-253597-10
Internet: http://www.mdc-ce.de For electronic publication only
Attachment of the certificate

No. D1251600049 Date 2020-04-06 Page 2 of 2

Product category Product Class Product code


ventilators Aeros 4300 IIb 17-423
Aeros 4300s
Aeros 4500
ventilators Aeros 4600 IIb 17-429
Aeros 4800
medical suction units Vacus 7209 IIa 10-208
Medical air compressors Dixion C34 IIb 10-972
phototherapy lamps BabyGuard U-1131 IIa 17-515
BabyGuard U-1133
infant incubator BabyGuard I-1103 IIb 12-113
BabyGuard I-1107
BabyGuard I-1120
BabyGuard I-1125
open radiant infant warmer BabyGuard W-1140 IIb 13-250
BabyGuard W-1140-02
BabyGuard W-1145
syringe pumps Instilar 1428 IIb 13-217
pulse oximeter Storm 5100 IIb 17-148
central monitoring station software CMS IIb 17-588

Head of Certification Body

mdc medical device certification GmbH


Kriegerstraße 6
D-70191 Stuttgart, Germany
Phone: +49-(0)711-253597-0
Fax: +49-(0)711-253597-10
Internet: http://www.mdc-ce.de For electronic publication only

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