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    ISO 13485: 2016

    Milenia Biotec GmbH
    Versailler Str. 1
    35394 Gießen
    Germany
    BSI logo

    Certificate Number: MD 816381
    Scope: Design and development, manufacture and distribution of in-vitro diagnostic lateral flow tests for Point-of-Care use in inflammation and coagulation diagnostics.

    Original Registration Date Effective Date Last Revision Date Expiry Date
    2025-04-02 2025-08-04 2025-07-16 2028-08-03