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Guide Fixation Screw Driver
EUDAMEDClass I (EU MDR)
Ref MGST0027Model Dental AccessoryRef MGST0028Model HandpieceModel Tools
Identity
- Trade Name
- Guide Fixation Screw Driver EUDAMEDHandpiece Guide Fixation Screw Driver EUDAMED
- Device Name
- Dental Accessory EUDAMEDTools EUDAMED
- Model / Reference
- Dental Accessory EUDAMEDMGST0027 EUDAMEDHandpiece EUDAMEDMGST0028 EUDAMEDTools EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DEMF000009412MGST00276N EUDAMED04260525163833 EUDAMEDD-DEMF000009412MGST00286Q EUDAMED
- Basic UDI-DI
- B-DEMF000009412MGST00276N EUDAMED426052516HandPFixtureUZ EUDAMEDB-DEMF000009412MGST00286Q EUDAMED
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMEDZ12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMEDEUDAMED
Reusable
Yes
EUDAMEDEUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Surgical screwdriver, reusable
Guide Fixation Screw Driver by Medigma Biomedical Gmbh — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical screwdriver, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-DEMF000009412MGST00276N | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-DEMF000009412MGST00276N | Class I | Active |
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Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (3)
- EUDAMED 9bc9d231-b8a6-40c3-ab09-f8e00634ee6c 61 fields · synced Oct 6, 2026
- EUDAMED 8743ad74-1d64-49b5-b255-1f120b108be1 61 fields · synced May 17, 2026
- EUDAMED 6490dfd6-6deb-4010-81c4-54acb266d9c0 61 fields · synced May 19, 2026