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Certified Management Systems

QMS, QMS Normenkonformität, QMS Produktion, Anhang V MDD, and Vollst. QMS, Anhang II MDD

Certificate Holder: Gebr. Brasseler GmbH & Co. KG

Test Mark Number: 0711107400

The certificate holder's Management System corresponds to standards:

  • ISO 9001:2008
  • EN ISO 13485:2012
The organization "Gebr. Brasseler GmbH & Co. KG" as named in the certificate was audited and certified by “TÜV Rheinland LGA Products GmbH“.
Certificate scopes:
  • QMS:
    Design and development, manufacture and distribution of medical devices (see attachment for products included) Products included: - Rotary and oscillating instruments for dentistry - Rotary instruments and saw blades for orthopedics, dermatology, surgery and ophthalmology - Posts, screws and prefabricated elements as well as auxiliary parts for the restoration of teeth - Dental implants - Composite systems for root post cementation and core build-up - Instruments for podiatry - Agents for the cleaning and disinfection of medical devices - Pins and screws for use in orthopedics Products included: - Rotary endodontic instruments - Filling material for root canals and paper points for drying the root canal - Dental hand pieces and contra-angles - Sterilization containers and bur blocks - Manual instruments and tools for use in dentistry - Elastomeric elements
  • QMS Normenkonformität:
    Design and development, manufacture and distribution of medical devices and products for dental laboratories and industry
  • QMS Produktion, Anhang V MDD:
    Rotary instruments for dentistry Replaces Approval, Registration-No.: DD 60023870 0001
  • Vollst. QMS, Anhang II MDD:
    Non-active medical devices (see attachment for products included) Replaces Approval, Registration-No.: HD 60028332 0001 Products included: - Rotary and oscillating instruments for dentistry - Rotary instruments and saw blades for orthopedics, dermatology, surgery and ophthalmology - Posts, screws and prefabricated elements as well as auxiliary parts for the restoration of teeth - Dental implants - Composite systems for root post cementation and core build-up - Instruments for podiatry - Agents for the cleaning and disinfection of medical devices - Pins and screws for use in orthopedics - Rotary endodentic instruments - Filling material for root canals and paper points for drying the root canal - Dental hand pieces and contra-angles - Elastomeric elements For the following devices the scope covers only the aspects of the manufacture concerned with the securing and maintaining sterile conditions: - Manual instruments and tools for use in dentistry
Description:

Das oben genannte Unternehmen verfügt über ein zertifiziertes Qualitätsmanagementsystem und erfüllt die definierten Anforderungen für den angegebenen Geltungsbereich.

Further information by the certificate holder: The certificate holder has not provided further information.
All certificates of Gebr. Brasseler GmbH & Co. KG:

5 certified management systems

Contact to the certificate holder: Gebr. Brasseler GmbH & Co. KG

Trophagener Weg 25
32657 Lemgo
Germany
E-mail: info@brasseler.de