Certified Management Systems

EN ISO 13485 and MDD Annex II excl. 4

Certificate Holder: medentis medical GmbH

Test Mark Number: 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

Further information by the certificate holder: The certificate holder has not provided further information.
Contact to the certificate holder: medentis medical GmbH

Walporzheimer Str. 48-52
53474 Bad Neuenahr-Ahrweiler