Certificate No. 60135992

Certificate Number: 60135992
Certificate Holder: Gebr. Brasseler GmbH & Co. KG

Trophagener Weg 25
32657 Lemgo
Germany
Scope:

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

Fulfilled Standards: EN ISO 13485:2016
Certificate Type: QMS

Quality Management System
EN ISO13485 quality management standard for medical devices and related services

The European standard EN ISO 13485 specifies requirements for a quality management system when an organization is required to demonstrate its ability to provide medical devices and related services that constantly meet customer requirements and applicable legal requirements.

Competent auditors analyze and evaluate the customer's quality management system. If all applicable requirements are met, its quality management system is certified according to EN ISO 13485.

The customer's quality management system is subject to regular monitoring.

Certified customers may use the test mark in their communication.

Further information on this service can be found here.