Certified Management System

EN ISO 13485

Certificate Holder: Chembio Diagnostics GmbH

Test Mark Number: 9000007939

The certificate holder's Management System corresponds to standard EN ISO 13485:2016.

The organization "Chembio Diagnostics GmbH" as named in the certificate was audited and certified by “TÜV Rheinland LGA Products GmbH“.
Certificate scope:
  • EN ISO 13485:

    Design and development, manufacture and distribution of instruments used in combination with in vitro diagnostic lateral flow assays

Further information by the certificate holder: The certificate holder has not provided further information.
Contact to the certificate holder: Chembio Diagnostics GmbH

Schwarzschildstr. 1
12489 Berlin
Germany