Scribd Logo
Upload

Welcome to Scribd!

  • 458 views

    ECG-CE Comen PDF

    Uploaded by

    Tehoptimed SA
    This certificate from DNV Business Assurance certifies that Shenzhen Comen Medical Instruments Co., Ltd.'s quality management system for the design, production, and testing of electrocardiographs has been assessed and found to comply with the EU Medical Device Directive. The certificate is valid until October 2017 and covers several electrocardiograph product models. DNV conducts periodic audits to ensure the quality system remains in compliance and may revoke the certificate if significant changes are made without approval.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    ECG-CE Comen PDF

    Uploaded by

    Tehoptimed SA
    458 views3 pages
    This certificate from DNV Business Assurance certifies that Shenzhen Comen Medical Instruments Co., Ltd.'s quality management system for the design, production, and testing of electrocardiographs has been assessed and found to comply with the EU Medical Device Directive. The certificate is valid until October 2017 and covers several electrocardiograph product models. DNV conducts periodic audits to ensure the quality system remains in compliance and may revoke the certificate if significant changes are made without approval.

    Original Title

    ECG-CE comen.pdf

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This certificate from DNV Business Assurance certifies that Shenzhen Comen Medical Instruments Co., Ltd.'s quality management system for the design, production, and testing of electrocardiographs has been assessed and found to comply with the EU Medical Device Directive. The certificate is valid until October 2017 and covers several electrocardiograph product models. DNV conducts periodic audits to ensure the quality system remains in compliance and may revoke the certificate if significant changes are made without approval.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    458 views3 pages

    ECG-CE Comen PDF

    Uploaded by

    Tehoptimed SA
    This certificate from DNV Business Assurance certifies that Shenzhen Comen Medical Instruments Co., Ltd.'s quality management system for the design, production, and testing of electrocardiographs has been assessed and found to comply with the EU Medical Device Directive. The certificate is valid until October 2017 and covers several electrocardiograph product models. DNV conducts periodic audits to ensure the quality system remains in compliance and may revoke the certificate if significant changes are made without approval.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 3

    DNV BUSINESS ASSURANCE

    EC CERTIFICATE - FULL QUALITY ASSURANCE SYSTEM


    Certificate No. 9436-2007-CE-NOR 3.0
    This Certificate consists of 3 pages

    This is to certify that the Quality Management System of

    Shenzhen Comen Medical Instruments Co., Ltd.


    South of Floor 7, Block 5 & Floor 6, Block 4, 4th Industrial Area of Nanyou, Nanshan District, Shenzhen,
    Guangdong, P. R. China
    for design, production and final product inspection/testing of

    Electrocardiograph
    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, 11 December 2012 15 October 2017

    For DET NORSKE VERITAS CERTIFICATION AS


    NORWAY

    Aud Løken Eiklid Notified Body No.: Mariann Jeremiassen


    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
    Page 1 of 3
    Cert. No.: 9436-2007-CE-NOR
    Rev. No.: 3.0
    Project No.: PRJC-24170-2007-PRC-RGC

    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 2007-10-15
    2 Extension in scope 2010-03-09
    3 Recertification 2012-12-11

    Products covered by this Certificate

    Product Description Product Class


    CM100, CM100A, CM300, CM300A, CM600, CM1200,
    Electrocardiograph IIa
    CM1200A, CM1200B

    The complete list of devices is filed with the Notified Body.

    Sites covered by this certificate


    South of Floor 7, Block 5 & Floor 6, Block 4, 4th Industrial Area of Nanyou, Nanshan District, Shenzhen,
    Guangdong, P. R. China

    EU Representative

    Wellkang Ltd t/a Wellkang Tech Consulting

    Suite B, 29 Harley Street, LONDON W1G 9QR, UK

    Page 2 of 3

    Det Norske Veritas AS, Veritasveien 1, 1322 Høvik, Norway. Tel: +47 67 57 9900 Fax: +47 6757 9911 www.dnv.com
    Cert. No.: 9436-2007-CE-NOR
    Rev. No.: 3.0
    Project No.: PRJC-24170-2007-PRC-RGC

    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

    Page 3 of 3

    Det Norske Veritas AS, Veritasveien 1, 1322 Høvik, Norway. Tel: +47 67 57 9900 Fax: +47 6757 9911 www.dnv.com

    You might also like