EU Quality Management System Certificate
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For electronic distribution only Nur zur elektronischen Verbreitung We hereby certify the company Medigma Biomedical GmbH Siemensstrafte 10 78564 Wehingen Germany the introduction and application of a quality management system in accordance with Annex IX, Chapter I and III of Regulation (EU) 2017/745 for conformity assessment. An audit by mdc has proven that this quality management system meets the following requirements: Annex IX - Chapter I (Quality Management System) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. Surveillance is carried out in accordance with Annex IX, Section 3 of Regulation (EU) 2017/745. This certificate from mdc medical device certification GmbH (Notified Body 0483) consists of 3 pages. Details about the devices covered as well as further information and conditions are contained on the following pages. Valid from 2023-11-14 Registration No. D1418500009 Valid until 2028-11-13 Report No. P22-01484-248168 , fur Gesundheitsschutz -g1 7T bei Arzneimitteln und | Medizinprodukten i mdc medical device certification GmbH | KriegerstraRe 6 | 70191 Stuttgart | Germany | www.mdc-ce.de

Registration No. D1418500009 Medigma Biomedical GmbH | SRN: DE-MF-000009412 Devices: Dental Implants: FixTite™-S dental implants Mars™ dental implants Fix-a-Dent™ dental implants Fix1™ dental implants Fix Konisch™ dental implants Grand Konisch™ dental implants Intended purpose: Medigma’s dental implants and abutments are intended to be used in conjunction with each other during implant surgical placement in the maxillary and/or mandibular arches to support single-unit or multiple-unit prosthetic restorations including cement-retained, screw-retained or overdenture restorations in partially...

Registration No. D1418500009 Medigma Biomedical GmbH | SRN: DE-MF-000009412 Freehand Surgery Handpiece Connected Tools Risk class: IIa Guided Surgery Drills Risk class: IIa Guided Surgery Handpiece Connected Tools Risk class: IIa Anchorage Screws Risk class: IIa Osteotomes Risk class: I (reusable) Guided Surgery Tissue Punches Risk class: IIa Notes: In the case of class I devices that are reusable surgical instruments the involvement of mdc is limited to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing...