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  • Certified Management Systems

    • Management Systems

      ISO 9001 and QMS

    • Certificate Holder

      Gebr. Brasseler GmbH & Co. KG

    • Test Mark Number

      0711107400

    The certificate holder's Management System corresponds to standards:

    1. EN ISO 13485:2016

    2. ISO 9001:2015

    Certificate scopes

    • ISO 9001

      Design and development, manufacture and distribution
      of medical devices and products for
      dental laboratories and industry

    • QMS

      Design and development, manufacture and distribution
      of non-active medical devices
      (see attachment for products included)
      Products included:
      - Rotary and oscillating instruments for dentistry
      dermatology, surgery and ophthalmology
      - Rotary instruments and saw blades for orthopedics,
      - Posts, screws and prefabricated elements as well as
      auxiliary parts for the restoration of teeth
      - Instruments for podiatry
      - Agents for the cleaning and disinfection of
      medical devices
      - Pins and screws for use in orthopedics
      Products included:
      - Rotary endodontic instruments
      drying the root canal
      - Filling material for root canals and paper points for
      - Dental hand pieces and contra-angles
      - Sterilization containers and bur blocks
      - Manual instruments and tools for use in dentistry
      - Elastomeric elements

    Certificates for these Management Systems

    Contact to the certificate holder

    Gebr. Brasseler GmbH & Co. KG

    Trophagener Weg 25
    32657 Lemgo
    Germany