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Certificates

Our quality management system is certified for the manufacture of medical devices according to DIN EN ISO 13485:2016.

We also hold a certificate in accordance with Annex IX Chapter I of Regulation (EU) 2017/745 on Medical Devices for the development, manufacture and distribution of our products.

 

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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