Certificates
Certificate of Registration QMS ISO 13485 2016
EU Quality Management System Certificate
Free sale certificate by Swiss agency for therapeutic products
TRATE AG is certified by:
Notified Body: BSI Group America Inc., USA (A Member of the BSI Group of Companies)
- Certification: ISO 13485:2016 (incl. specific requirements for Canada and Australia)
- Certificate No.: MDSAP 796894
- Certification scope: Design, development, manufacturing, and distribution of sterile and non-sterile dental implants, superstructures and associated instruments.
Notified Body: BSI Group The Netherlands B.V., Netherlands (A Member of the BSI Group of Companies), NB No. 2797
- Certification: Quality Management System in accordance with Regulation (EU) 2017/745
- Certificate No.: MDR 757191 R000
- Certification scope: Annex IX, Chapter I & III – for the placement of Class III and Class IIb implantable devices on the market


