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    Declaration of Conformity: B.M.Tech. Worldwide Co., LTD

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    Nguyen Quoc Huy
    This document declares that a bone absorptiometric x-ray system called the OsteoPro, manufactured by B.M.Tech. Worldwide Co., Ltd., meets the provisions of the EC Medical Device Directive 93/42/EEC. The device is classified as a Class IIb medical device and complies with relevant standards, including EN 60601-1 for electrical equipment safety and EN 55011 for electromagnetic compatibility. The declaration was issued by B.M.Tech. Worldwide Co., Ltd.'s president on November 29, 2013.

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    Declaration of Conformity: B.M.Tech. Worldwide Co., LTD

    Uploaded by

    Nguyen Quoc Huy
    21 views1 page
    This document declares that a bone absorptiometric x-ray system called the OsteoPro, manufactured by B.M.Tech. Worldwide Co., Ltd., meets the provisions of the EC Medical Device Directive 93/42/EEC. The device is classified as a Class IIb medical device and complies with relevant standards, including EN 60601-1 for electrical equipment safety and EN 55011 for electromagnetic compatibility. The declaration was issued by B.M.Tech. Worldwide Co., Ltd.'s president on November 29, 2013.

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    OsteoPro(DEXA BMD)_DOC

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    This document declares that a bone absorptiometric x-ray system called the OsteoPro, manufactured by B.M.Tech. Worldwide Co., Ltd., meets the provisions of the EC Medical Device Directive 93/42/EEC. The device is classified as a Class IIb medical device and complies with relevant standards, including EN 60601-1 for electrical equipment safety and EN 55011 for electromagnetic compatibility. The declaration was issued by B.M.Tech. Worldwide Co., Ltd.'s president on November 29, 2013.

    Copyright:

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

    Declaration of Conformity: B.M.Tech. Worldwide Co., LTD

    Uploaded by

    Nguyen Quoc Huy
    This document declares that a bone absorptiometric x-ray system called the OsteoPro, manufactured by B.M.Tech. Worldwide Co., Ltd., meets the provisions of the EC Medical Device Directive 93/42/EEC. The device is classified as a Class IIb medical device and complies with relevant standards, including EN 60601-1 for electrical equipment safety and EN 55011 for electromagnetic compatibility. The declaration was issued by B.M.Tech. Worldwide Co., Ltd.'s president on November 29, 2013.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    B.M.Tech. Worldwide Co., Ltd.

    (Sangdaewon-dong) 1001, 1002, 1003, 5th, Jungang Induspia, 137,


    Sagimakgol-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea
    Tel. +82-31-739-5544 / Fax. +82-31-739-5545 / www.bmtech21.com

    Declaration of Conformity
    In accordance with EC Medical Directive 93/42/EEC, Annex Ⅴ

    We herewith declare that the above mentioned product meets the provisions of the Council Directive
    93/42/EEC for medical device. All supporting documentation is related under the premises of the
    manufacturer.
    If the device is modified without the agreement of the undersigned, this declaration becomes invalid.

    Description of Equipment : Bone absorptiometric x-ray system, dual-energy

    Calssfication Class Ⅱb (rule10)

    Model Name : OsteoPro

    Relevant EC Directive : EC Medical Device Directive 93/42/EEC


    amended by 2007/47/EC.
    EN 60601-1:1990+A1:1993+A11:1993
    Applied Standards :
    +A12:1993+A2:1995+A13:1996
    EN 60601-1-2:2007
    EN 55011:2007

    Manufacturers Registered Name : B.M.Tech. Worldwide Co., Ltd.

    (Sangdaewon-dong) 1001, 1002, 1003, 5th, Jungang Induspia,


    Manufacturers Registered Address :
    137, Sagimakgol-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do,
    Korea
    Date: November 29, 2013

    Mr. Han, Seung-Moo / President


    B.M.Tech. Worldwide Co., Ltd.

    B.M.Tech. Worldwide Co., Ltd.

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