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  • Certified Management Systems

    • Management Systems

      EN ISO 13485 and MDD Annex II excl. 4

    • Certificate Holder


    • Test Mark Number


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

    Certificate scopes

    • EN ISO 13485

      Design and Development, Manufacture, Distribution and Servicing of Ultrasound Diagnostic Equipment and Tourniquet System

    • MDD Annex II excl. 4

      Ultrasound Diagnostic Equipment

    Certificates for these Management Systems

    Contact to the certificate holder


    2-6-1, Sakae, Naka-ku
    Nagoya-shi, Aichi 4600008