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    EC Certificate

    Uploaded by

    lakmal-weeeera12
    This document is an EC Certificate issued to Oxytek Medical Technology Co., Ltd. that certifies their quality assurance system for the design, production, and testing of oxygen concentrators has been assessed and found to comply with the relevant European directives. The certificate is valid until July 31st, 2022 and covers specific oxygen concentrator product models that are classified as Class IIa medical devices. Oxytek's manufacturing site in China and their EU representative are also listed.

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

    EC Certificate

    Uploaded by

    lakmal-weeeera12
    136 views3 pages
    This document is an EC Certificate issued to Oxytek Medical Technology Co., Ltd. that certifies their quality assurance system for the design, production, and testing of oxygen concentrators has been assessed and found to comply with the relevant European directives. The certificate is valid until July 31st, 2022 and covers specific oxygen concentrator product models that are classified as Class IIa medical devices. Oxytek's manufacturing site in China and their EU representative are also listed.

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    This document is an EC Certificate issued to Oxytek Medical Technology Co., Ltd. that certifies their quality assurance system for the design, production, and testing of oxygen concentrators has been assessed and found to comply with the relevant European directives. The certificate is valid until July 31st, 2022 and covers specific oxygen concentrator product models that are classified as Class IIa medical devices. Oxytek's manufacturing site in China and their EU representative are also listed.

    Copyright:

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

    EC Certificate

    Uploaded by

    lakmal-weeeera12
    This document is an EC Certificate issued to Oxytek Medical Technology Co., Ltd. that certifies their quality assurance system for the design, production, and testing of oxygen concentrators has been assessed and found to comply with the relevant European directives. The certificate is valid until July 31st, 2022 and covers specific oxygen concentrator product models that are classified as Class IIa medical devices. Oxytek's manufacturing site in China and their EU representative are also listed.

    Copyright:

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

    EC Certificate

    Full Quality Assurance System


    Certificate No.: Project No.: Valid until:
    10014-2017-CE-RGC-NA-PS Rev 0.0 PRJC-538703-2016-PRC-CHN 31 July 2022

    This is to certify that the quality system of:

    Oxytek Medical Technology Co., Ltd.


    10-2, Guang Long Industrial Park, South 1st Rd, Chencun Town, Shunde District, Foshan City,
    Guang Dong Province, China

    For design, production and final product inspection/testing of:

    Oxygen concentrator

    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 of the product(s) and conditions for certification are given overleaf.

    Place and date: For:


    Høvik, 31 July 2017 DNV GL NEMKO PRESAFE AS

    Bjørg Synnøve Nesgård

    PROD 021 The Certificate has been digitally signed.


    Notified Body No.: 2460 See www.presafe.com/digital_signatures for more info

    Notice: The Certificate is subject to terms and conditions as set out in the Certification Agreement. Failure to comply may render this Certificate invalid.

    MSD-CO-078 DNV GL NEMKO PRESAFE AS - Veritasveien 3, N-1363 Høvik, Norway - Registered Enterprise No: NO 997 067 401 MVA Page 1 of 3
    EC Certificate
    Full Quality Assurance System
    Certificate No.: Project No.: Valid until:
    10014-2017-CE-RGC-NA-PS Rev 0.0 PRJC-538703-2016-PRC-CHN 31 July 2022

    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
    0.0 Original Certificate 2017-07-31

    Products covered by this Certificate:

    Product Description Product Name Class


    OX-2A, OX-5A, OX-10A, OX-2B, OX-5B, OX-
    Oxygen concentrator IIa
    10B

    The complete list of devices is filed with the Notified Body

    Sites covered by this certificate

    Oxytek Medical Technology Co., Ltd.

    10-2, Guang Long Industrial Park, South 1st Rd, Chencun town, Shunde District, Foshan city,
    Guang Dong Province, China

    EU Representative

    CGI Business Trading and Consulting e.K

    Hans-Bethe-Str.1, 60438 Frankfurt am Main, Germany

    MSD-CO-078 DNV GL NEMKO PRESAFE AS - Veritasveien 3, N-1363 Høvik, Norway - Registered Enterprise No: NO 997 067 401 MVA Page 2 of 3
    EC Certificate
    Full Quality Assurance System
    Certificate No.: Project No.: Valid until:
    10014-2017-CE-RGC-NA-PS Rev 0.0 PRJC-538703-2016-PRC-CHN 31 July 2022

    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 Presafe of any intended updating of the quality system and Presafe 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. Presafe 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 Presafe.

    End of Certificate

    MSD-CO-078 DNV GL NEMKO PRESAFE AS - Veritasveien 3, N-1363 Høvik, Norway - Registered Enterprise No: NO 997 067 401 MVA Page 3 of 3

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