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TMA/FC Female Hand Hex Driver - Long
EUDAMEDClass I (EU MDR)
Ref TMA-SHHLModel Dental AccessoryModel Hand Driver
Identity
- Trade Name
- TMA/FC Female Hand Hex Driver - Long EUDAMED
- Device Name
- Dental Accessory EUDAMED
- Model / Reference
- Dental Accessory EUDAMEDTMA-SHHL EUDAMEDHand Driver EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DEMF000009412TMASHHLPR EUDAMED04260525163123 EUDAMED
- Basic UDI-DI
- B-DEMF000009412TMASHHLPR EUDAMED426052516HandDriverXR EUDAMED
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
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
TMA/FC Female Hand Hex Driver - Long 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-DEMF000009412TMASHHLPR | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-DEMF000009412TMASHHLPR | Class I | Active |
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Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (2)
- EUDAMED 3a1acf6f-932a-4c5a-a19c-6ac94ab10359 61 fields · synced Jul 21, 2026
- EUDAMED 7e279561-b23a-4338-bf96-328cdec64f56 61 fields · synced May 19, 2026