Print Page Share Page Contact

Thank you for your message.
We will get back to you.

Contact TÜV Rheinland

Sorry. This action failed due to a technical error. Please try again later.

Please fill out all fields marked with *.

Please describe your request as exactly as possible.
We will answer as soon as possible.
  • Certified Management Systems

    • Management Systems

      EN ISO 13485, MDD Annex II excl. 4, and MDR Ann. IX, Chapt I

    • Certificate Holder

      medentis medical GmbH

    • Test Mark Number


    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

    • MDR Ann. IX, Chapt I

      Products of Class llb:
      Odontological Prostheses
      - P010201 - Dental Implants and Accessories

      Products of class I, sterile:
      - Q010207 - Dental Impression Devices for Prosthetic Dentistry

      The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions

    Certificates for these Management Systems

    Contact to the certificate holder

    medentis medical GmbH

    Walporzheimer Str. 48-52
    53474 Bad Neuenahr-Ahrweiler