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Gebr. Brasseler GmbH & Co. KG
System Certificates
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Gebr. Brasseler GmbH & Co. KG
Trophagener Weg 25
32657 Lemgo
Germany
3 certified management systems
Certificate Type
Scope
Details
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
0711107400
QMS Produktion, Anhang V MDD
Rotary instruments for dentistry Replaces Approval, Registration-No.: DD 60091373 0001
60135990
Vollst. QMS, Anhang II MDD
Non-active medical devices (see attachment for products included) Replaces Approval, Registration-No.: HD 60091372 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 - 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 - Manual instruments and tools for use in dentistry 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
60135991
