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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:
EN ISO 13485:2016
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