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Certified Management Systems

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
Certificate scopes:
  • 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:

Gebr. Brasseler GmbH & Co. KG holds a quality management system according to EN ISO 9001:2008 and EN ISO 13485:2012/AC:2012 for design and developement, manufacturing and distribution of medical devices and products for dental laboratories and industry of the following categories: 

  • 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 
  • Instruments for podiatry 
  • Composite System for root post cementation and core build-up
  • Implants as well as auxiliary parts for transdental fixation of teeth and as abutments for the fixation of dentures
  • Dental handpieces 

To download the certificates, please click on the respective certificate number below.

You can find more information at www.brasseler.de and at www.kometmedical.de.

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