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  • Certificate of Ce Registration 35 - 7

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    khang baointl
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    This certificate certifies that mdi Europa GmbH will serve as the authorized representative for Unique International S.A.S. as required by European medical device directives, performing all required duties. Three medical devices from the manufacturer have been registered with the German competent authorities, including condoms, probe covers, and a lubricating jelly, classified between Class I and IIb. The manufacturer has provided all necessary documentation and a declaration of conformity confirming the devices meet essential safety requirements.

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    This certificate certifies that mdi Europa GmbH will serve as the authorized representative for Unique International S.A.S. as required by European medical device directives, performing all required duties. Three medical devices from the manufacturer have been registered with the German competent authorities, including condoms, probe covers, and a lubricating jelly, classified between Class I and IIb. The manufacturer has provided all necessary documentation and a declaration of conformity confirming the devices meet essential safety requirements.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    24 views1 page

    Certificate of Ce Registration 35 - 7

    Uploaded by

    khang baointl
    This certificate certifies that mdi Europa GmbH will serve as the authorized representative for Unique International S.A.S. as required by European medical device directives, performing all required duties. Three medical devices from the manufacturer have been registered with the German competent authorities, including condoms, probe covers, and a lubricating jelly, classified between Class I and IIb. The manufacturer has provided all necessary documentation and a declaration of conformity confirming the devices meet essential safety requirements.

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    © All Rights Reserved
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    of 1

    Certificate of

    CE-Registration
    This is to certify that, in accordance with either medical device Directive 93/42/EEC as amended by 2007/47/EC or Directive 98/79/EC,
    mdi Europa GmbH agree to perform all duties and responsibilities as the Authorized Representative for

    Unique International S.A.S


    Cra 19A # 196-23
    Bogota
    Colombia

    as stipulated and demanded by the afore-mentioned Directives. The German competent authorities have allocated the medical devices
    of the manufacturer the following registration numbers:

    UMDNS Code Description Classification Registration Number


    10985 Condom made of synthetic resin IIb DE/CA09/0760/U04/001-02

    10985 Probe covers made of synthetic resin I DE/CA09/0760/U04/003-02

    12401 Lubricating Jellies (oil based) Ultralub personal I DE/CA09/0760/U04/002-01


    lubricant

    The manufacturer has provided mdi Europa with all necessary documentation, together with an appropriate Declaration of Conformity
    confirming that the medical devices fulfill the essential requirements of either Directive 93/42/EEC as amended by 2007/47/EC or
    98/79/EC. A safety officer has been appointed for Germany and therefore is in full compliance with § 31 MPG.

    Signed on 29 June 2020

    Werner Sander
    President

    Page 1 of 1

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