DNV BUSINESS ASSURANCE
EC CERTIFICATE - FULL QUALITY ASSURANCE SYSTEM
Certificate No. 54317-2009-CE-RGC-NA 11.0
This Certificate consists of 4 pages
This is to certify that the Quality Management System of
SonoScape Company Limited
P. R. China
for design, production and final product inspection/testing of
Ultrasonic Diagnostic Systems
has been assessed with respect to
the conformity assessment procedure described in Article 11.3.a and Annex II excluding section 4
(Module H) of Council Directive 93/42/EEC on Medical Devices, as amended, and found to comply
Further details are given overleaf
Place and date: This Certificate is valid until:
Høvik, 01 July 2014 02 July 2019
For DET NORSKE VERITAS CERTIFICATION AS
NORWAY
Cecilie Gudesen Torp Notified Body No.: Dennis Lin
Certification Manager 0434 Technical Reviewer
This Certificate has been digitally signed. See www.dnv.com/digitalsignatures for more info
Notice: The certificate is subject to terms and conditions overleaf. Any significant changes in design or construction may render this certificate invalid.
If any person suffers loss or damage which is proved to have been caused by any negligent act or omission of Det Norske Veritas, then Det Norske Veritas shall pay compensation to such person for his proved direct loss or damage. However, the compensation
shall not exceed an amount equal to ten times the fee charged for the service in question, provided that the maximum compensation shall never exceed USD 300.000. In this provision “Det Norske Veritas” shall mean the Foundation Det Norske Veritas as well as
all its subsidiaries, directors, officers, employees, agents and any other acting on behalf of Det Norske Veritas.
Det Norske Veritas AS, Veritasveien 1, 1322 Høvik, Norway. Tel: +47 67 57 9900 Fax: +47 6757 9911 www.dnv.com
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Cert. No.: 54317-2009-CE-RGC-NA
Rev. No.: 11.0
Project No.: PRJC-59777-2008-PRC-CHN
Jurisdiction
Application of Council Directive 93/42/EEC of 14 June 1993, adopted as ‘Forskrift for Medisinsk
Utstyr’ by the Norwegian Ministry of Health and Care Services.
Certificate history
Revision Description Issue Date
1 Original certificate 2004-07-02
2 Recertification 2009-07-02
3 Extension of Scope – New product added 2010-03-19
4 Extension of Scope- New product added 2010-07-08
5 Change of model name for one device 2011-05-20
6 Extension of Scope – New product added 2011-11-09
7 Extension of Scope – New product added 2012-06-05
8 Extension of Scope – New product added 2012-09-06
9 Extension of Scope – New product added 2013-01-04
10 Extension of Scope – New product added 2013-08-15
11 Recertification 2014-07-02
Products covered by this Certificate
Product Description Product Class
Digital Color Doppler ultrasound System SSI-5000, SSI-4000, SSI-2000, SSI-1500 IIa
Digital Color Doppler ultrasound System SSI-6000, SSI-5800, SSI-5500, SSI-5500BW IIa
Digital Color Doppler ultrasound System S20 Exp, S20 Pro, S20, S15 IIa
Portable Digital Color Doppler ultrasound S8, S8 Pro, S6 Pro, S6, S6BW IIa
System
Mobile Digital Color Doppler ultrasound SSI-8000 Exp, SSI-8000 Pro, SSI-8000, IIa
System SSI-8000 PE
Portable Ultrasonic Diagnostic System A6T, A6, A5 IIa
Mobile Ultrasonic Diagnostic System A8T, A8, A7 IIa
Digital Color Doppler ultrasound System S11 Exp, S11 Pro, S11, S11 N, S11 BW IIa
Digital Color Doppler ultrasound System S40 Exp, S40 Pro, S40, S35 IIa
Digital Color Doppler ultrasound System SSI-5000N, SSI-4000N, SSI-3000N, IIa
SSI-2000N, SSI-1500N
Portable Digital Color Doppler ultrasound S8N, S6N, S2N, S2, S2BW IIa
HEAD OFFICE: Det Norske Veritas AS, Veritasveien 1, 1322 Høvik, Norway. Tel: +47 67 57 9900 Fax: +47 6757 9911 www.dnv.com
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Cert. No.: 54317-2009-CE-RGC-NA
Rev. No.: 11.0
Project No.: PRJC-59777-2008-PRC-CHN
System
Portable Digital Color Doppler ultrasound S9 Exp, S9 Pro, S9, S8 Exp, S7, SSI-980 IIa
System
Digital Color Doppler ultrasound System S30 Exp, S30 Pro, S30, S25 IIa
Digital Color Doppler ultrasound System S12 Exp, S12 Pro, S12, S11 Plus, M12 IIa
Digital Color Doppler ultrasound System S22 Exp, S22 Pro, S22, S20N, M22 IIa
The complete list of devices is filed with the Notified Body.
Sites covered by this certificate
Site Name Address
Yizhe Building, Yuquan Road, Nanshan, Shenzhen 518051,
SonoScape Company Limited
P. R. China
EU Representative
SONOMED, Via Luigino Tandura, 74-00128 Rome, Italy
HEAD OFFICE: Det Norske Veritas AS, Veritasveien 1, 1322 Høvik, Norway. Tel: +47 67 57 9900 Fax: +47 6757 9911 www.dnv.com
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Cert. No.: 54317-2009-CE-RGC-NA
Rev. No.: 11.0
Project No.: PRJC-59777-2008-PRC-CHN
Terms and conditions
The certificate is subject to the following terms and conditions:
• Any producer (see 2001/95/EC for a precise definition) is liable for damage caused by a defect in his product(s), in
accordance with directive 85/374/EEC, as amended, concerning liability of defective products.
• The certificate is only valid for the products and/or manufacturing premises listed above.
• The Manufacturer shall fulfil the obligations arising out of the quality system as approved and uphold it so that it
remains adequate and efficient.
• The Manufacturer shall inform the local DNV Office of any intended updating of the quality system and DNV will
assess the changes and decide if the certificate remains valid.
• Periodical audits will be held, in order to verify that the Manufacturer maintains and applies the quality system DNV
reserves the right, on a spot basis or based on suspicion, to pay unannounced visits.
The following may render this Certificate invalid:
• Changes in the quality system affecting production.
• Periodical audits not held within the allowed time window.
Conformity declaration and marking of product
When meeting with the terms and conditions above, the producer may draw up an EC declaration of conformity and legally
affix the CE mark followed by the Notified Body identification number of DNV.
END OF CERTIFICATE
HEAD OFFICE: Det Norske Veritas AS, Veritasveien 1, 1322 Høvik, Norway. Tel: +47 67 57 9900 Fax: +47 6757 9911 www.dnv.com
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