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    • Certified Management Systems

    • Management Systems

      EN ISO 13485 and MDD Annex II excl. 4

    • Certificate Holder

      medentis medical GmbH

    • Test Mark Number

      9000009561

    9000009561

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

    Certificate scopes

    • EN ISO 13485

      Design and development, manufacture, distribution and warehousing of products related to dental implantology

    • MDD Annex II excl. 4

      Products related to dental implantology

      Products included:

      - Dental Implants
      - Dental Abutments
      - Dental Drills
      - Healing Caps, dental
      - Cover Screws, dental
      - Instruments, dental

      For the following devices the scope covers only the aspects of the manufacture concerned with the securing and maintaining sterile conditions:

      - Instruments for dental impression

    Certificates for these Management Systems

    Contact to the certificate holder

    medentis medical GmbH

    Walporzheimer Str. 48-52
    53474 Bad Neuenahr-Ahrweiler
    Germany