Certified 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
The organization "Gebr. Brasseler GmbH & Co. KG" as named in the certificate was audited and certified by “TÜV Rheinland LGA Products GmbH“.
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 - 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 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
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Gebr. Brasseler GmbH & Co. KG Trophagener Weg 25 32657 Lemgo Germany |