CERTIFICATE This is to certify that the company FMZ GmbH 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 incl. Implants, Abutments, Surgical Kits, Drills, Screws, Dental Instruments and Accessories. -CND Through an audit, documented in a report, performed by DQS Medizinprodukte GmbH, it was verified that the management system fulfills the requirements of the following standard: ISO 13485 : 2016 including applicable country-specific regulatory requirements, as indicated below the scope (full references of abbreviations are listed in the annex) Effective date Expiry date Sigrid Uhlemann Managing Director Szymon Kurdyn Product Manager August-Schanz-Straße 21, 60433 Frankfurt am Main, Tel. +49 (0) 69 95427-300, [email protected] DQS Medizinprodukte GmbH is recognized under the Medical Devices Single Audit Program. Visit https://www.mydqs.com/en/customers/customer-database.html to validate this certificate. Full references of country-specific requirements of MDSAP participating Regulatory Authorities
Open the catalog to page 1Charles Darwin Ring 3a 18059 Rostock Germany Certificate registration No.: 204456 MDSAP16 Certificate unique ID: 170776290 Effective date: 2021-07-12 Charles Darwin Ring 3a 18059 Rostock Germany Design and Development, Manufacturing and Distribution of Dental Implant Systems incl. Implants, Abutments, Surgical Kits, Drills, Screws, Dental Instruments and Accessories. This annex is only valid in connection with the above-mentioned certificate.
Open the catalog to page 2United States Certificate registration No.: 204456 MDSAP16 Certificate unique ID: 170776290 Effective date: 2021-07-12 Abbreviation Jurisdiction Reference AUS Australia (a) Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 3, Part 1 - Full Quality Assurance Procedure (b) Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 3, Part 4 - Production Quality Assurance Procedure CND Canada Medical Device Regulations SOR/98-282, Part 1 JPN Japan MHLW Ministerial Ordinance No. 169 (2004) as amended by MHLW Ordinance No. 128 (2014), Articles 4 to 68 Japan PMD Act (as applicable)
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