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Certificates

As part of the group of companies, Hegewald Medizinprodukte GmbH produces medical devices under a certified quality management system in accordance with DIN EN ISO 13485:2016. A conformity assessment procedure in accordance with Annex IX of Regulation (EU) 2017/745 for medical devices was carried out and confirmed with the involvement of a notified body.

Certificate EN ISO 13485:2016

 

EC Declaration of Conformity Annex IX

 

HEMEDIS GmbH

Forstweg 8

09600 Weißenborn/Erzgeb.

Germany

phone: +49 (0) 37323 1553-0

fax: +49 (0) 37323 1553-30

info@hemedis.de

Webmail

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