Certified Management Systems

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

The certificate holder's Management System corresponds to standards:

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

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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