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  • Certified Management System

    • Management Systems

      EN ISO 13485

    • Certificate Holder

      Milenia Biotec 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, Manufacturing and Distribution of in-vitro diagnostic lateral flow Tests for Point-of-Care use in inflammation and coagulation diagnostics

    Certificate for this Management System

    Contact to the certificate holder

    Milenia Biotec GmbH

    Versailler Str. 1
    35394 Gießen