MSDI Ltd manufactures under a certified quality management system. MSDI products hold the following certifications, clearances and market registrations. Regulatory status varies by product and market.
- CE MDR 2017/745 – Certificate (PDF)
- FDA 510(k) K191443 (cleared for select sizes) – FDA database entry
- ISO 13485:2016 – Certificate (PDF)
- TGA Australia – Implants (PDF) | Abutments (PDF)
- EC Declarations of Conformity – Implants and abutments (DoC-01 Rev.10) | Dental accessories and tools (DoC-02 Rev.19)
- Free Sale Certificate (valid until 2028) – Certificate (PDF)
EU Authorized Representative
MedNet EC-REP IIb GmbH
Borkstrasse 10
48163 Münster, Germany