TIANJIN LINKANG MEDICAL APPARATUS CO.,LTD
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Add: ZhangJiaDi Village, WangQingTuo Town, WuQing District, TianJin, China

General manager: Miss.Carry

Tel: +86-022-29512420
Mob: +8613302033255
E-mail: carry@tianjinlinkang.com

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Medical Device CE Certificate Category
Jan 23, 2018

CE certificate is an important certificate for the export of medical devices to the EU countries, such as wheelchairs, walker, medical beds want to export to the European Union, all needs supply CE certificate.

There are several types of CE certificates as follows:

(1) Declaration of conformity / Declaration of compliance "Declaration of conformity", this certificate is a self-declaration, should not be issued by a third-party agency or testing and certification body, therefore, can be used in the EU format, "Declaration of Conformity "instead.

(2) Certificate of Compliance / Certificate of Compliance "This is a Declaration of Conformity issued by a third party = (agency or test certification body) and must be accompanied by a technical document TCF such as a test report. If there is no test report Can be handled by a third party agency. At the same time, companies have to sign "Declaration of Conformity."

(3) EC Attestation of conformity This is a certificate issued by the Notified Body (NB). Only the NB is eligible to issue a CE Type Declaration of EC Type according to EU regulations. Can be used as customs clearance, a one-time certificate.


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    Add: ZhangJiaDi Village, WangQingTuo Town, WuQing District, TianJin, China

    General manager: Miss.Carry

    Tel: +86-022-29512420
    Mob: +8613302033255
    E-mail: carry@tianjinlinkang.com

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