Certificates

As a manufacturer of medical equipment, Amplivox is certified to ISO 13485:2016, the Medical CE-Mark and the Medical Device Single Audit Program (MDSAP). You will find the corresponding documents below.

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ISO certification

Amplivox Ltd is certified to the requirements of ISO 13485:2016.

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Medical CE-Mark

Amplivox Ltd meets the requirements pursuant to Regulation (EU) 2017/745 on Medical Devices, Annex IX Chapters I and III. Approval is made by TÜV SÜD identification No. 0123.

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MDSAP

Amplivox is certified to the requirements of the Medical Device Single Audit Program (MDSAP).

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