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1.27 Hex Hand Driver - Medium
EUDAMEDClass I (EU MDR)
Ref SHHMModel Hand DriverModel Dental Accessory
Identity
- Trade Name
- 1.27 Hex Hand Driver - Medium EUDAMED
- Device Name
- Dental Accessory EUDAMED
- Model / Reference
- Hand Driver EUDAMEDSHHM EUDAMEDDental Accessory EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260525162164 EUDAMEDD-DEMF000009412SHHMNQ EUDAMED
- Basic UDI-DI
- 426052516HandDriverXR EUDAMEDB-DEMF000009412SHHMNQ EUDAMED
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
1.27 Hex Hand Driver - Medium by Medigma Biomedical Gmbh — Class I — MDD, MDR — 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/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 426052516HandDriverXR | Class I | Active |
| EUDAMED | European Union | CE/MDR | 426052516HandDriverXR | Class I | Active |
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Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (2)
- EUDAMED e0c65320-2d21-4b3a-859a-98d8dd1a7159 61 fields · synced Jul 12, 2026
- EUDAMED d01266d8-832b-4f2e-8b4a-06653aa6d9aa 61 fields · synced May 19, 2026