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CERTIFICATE

Medical Device Quality Management System

ISO 13485 : 2016

This is to certify that:

HUMAN GERMANY

Gesellschaft für Biochemica und Diagnostica mbH Max-Planck-Ring 21 65205 Wiesbaden Germany with the location Stegelitzer Straße 3 39126 Magdeburg


Hold Certificate No:

9QARYMOZ


Isocerts assessed and approved that the firm meets the requirements for the designated standard.

Scope


for the development, manufacturing and distribution of reagents, reagent products, calibrators and control materials for clinical chemistry. haematology, haemostasis, immune chemistry as well as analyzers for in-vitro diagnosis. distribution of test kits for molecular biology analyses as well as rapid tests for the diagnosis of infectious diseases.

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Manager Of System Certification

Initial Issue Date: 31-05-2023

Validity of this certificate: 30-05-2025



The validity of this certificate is depend on the success of surveillance assessments
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