Certificate Overview:

This document certifies that FMZ GmbH, located at Charles Darwin Ring 3a, 18059 Rostock, Germany, has implemented and maintains a Quality Management System.

Scope of Certification:

• Design and development, manufacturing, and distribution of dental implant systems, including implants, abutments, surgical kits, drills, screws, dental instruments, and accessories.
• Development, manufacturing, and distribution of fine mechanical products for medical use.

Audit and Standards:

The certification was granted following an audit conducted by DQS Medizinprodukte GmbH, confirming compliance with the following standards:

• DIN EN ISO 13485: 2016 + AC: 2017-07
• EN ISO 13485: 2016 + AC: 2016
• ISO 13485: 2016

Certificate Details:

• Certificate Registration No.: 204456 MP2016
• Certificate Unique ID: 170776291
• Effective Date: 2021-09-27
• Expiry Date: 2024-09-26

Issuing Body:

The certificate was issued by DQS Medizinprodukte GmbH, with Sigrid Uhlemann as the Managing Director and Dr. Thomas Feldmann as the Head of Certification Body.