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  • Certified Management Systems

    • Management Systems

      EN ISO 13485 and ISO 9001

    • Certificate Holder

      GENSPEED Biotech GmbH

    • Test Mark Number

      0000058115

    The certificate holder's Management System corresponds to standards:

    1. EN ISO 13485:2016

    2. ISO 9001:2015

    Certificate scopes

    • EN ISO 13485

      Design and development, manufacture and distribution of molecular diagnostic test kits and instruments for the detection of nosocomial infections, periodontitis and peri-implantitis.

      Design and development of immunoassays for the detection and/ or quantification of infectious diseases and inflammatory markers.

      Installation and service of instruments.

    • ISO 9001

      Design and development, manufacture and distribution of test kits and analysis instruments (including installation and service) for detection of various analytes in sample material.

    Certificates for these Management Systems

    Contact to the certificate holder

    GENSPEED Biotech GmbH

    Gewerbepark 2
    4261 Rainbach
    Austria