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  • Certified Management Systems

    • Management Systems

      EN ISO 13485 and MDD Annex II excl. 4

    • Certificate Holder

      Fischer ANalysen Instrumente GmbH

    • Test Mark Number


    Certificate scopes

    • EN ISO 13485

      Design and development, production, distribution, installation and service of in vitro diagnostic medical equipment and medical devices for respiratory gas analysis devices and distribution of consumables

    • MDD Annex II excl. 4

      Aspects of manufacture concerned with the conformity of
      medical devices for respiratory gas analysis
      with the metrological requirements

    Certificates for these Management Systems

    Contact to the certificate holder

    Fischer ANalysen
    Instrumente GmbH
    Brahestr. 25-27
    04347 Leipzig