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Certificate
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Certificate Overview
This document certifies that Medigma Biomedical GmbH has implemented a quality management system in accordance with EN ISO 13485 standards. The certification covers the design, manufacturing, storage, and marketing of dental implants, abutments, drills, surgical instruments, and associated accessories.
This document certifies that Medigma Biomedical GmbH has implemented a quality management system in accordance with EN ISO 13485 standards. The certification covers the design, manufacturing, storage, and marketing of dental implants, abutments, drills, surgical instruments, and associated accessories.
Certification Details
- Company: Medigma Biomedical GmbH
- Address: Siemensstraße 10, 78564 Wehingen, Germany
- Certification Body: mdc medical device certification GmbH
- Standard: EN ISO 13485:2016 + AC:2018 + A11:2021 - ISO 13485:2016
- Validity: From 2023-11-14 to 2026-11-13
- Registration No.: D1418500008
- Report No.: P22-01484-248171
Key Points
- The quality management system has been audited and meets regulatory requirements.
- The certification is valid for three years, ensuring compliance with international standards for medical devices.
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Catalog excerpts
For electronic distribution only Nur zur elektronischen Verbreitung We hereby certify the company Medigma Biomedical GmbH Siemensstrafte 10 78564 Wehingen Germany Design, Manufacturing, Storage and Marketing of dental implants, abutments, drills, surgical instruments and associated accessories An audit by mdc has proven that this quality management system meets the requirements of the following standard: Medical devices - Quality management systems - Requirements for regulatory purposes Valid from 2023-11-14 Registration No. D1418500008 Valid until 2026-11-13 Report No. P22-01484-248171 mdc medical device certification GmbH | KriegerstraRe 6 | 70191 Stuttgart | Germany | www.mdc-ce.de
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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.