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  • Certified Management System

    • Management Systems

      EN ISO 13485

    • Certificate Holder

      LIONEX GmbH

    • Test Mark Number


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

    Certificate scope

    • EN ISO 13485

      Design and development, manufacture and distribution of in-vitro diagnostic reagents and test kits based on ELISA and rapid tests for the infectious diseases, inflammatory and thrombosis related markers

    Certificate for this Management System

    Contact to the certificate holder


    Salzdahlumer Str. 196
    38126 Braunschweig