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