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TMA/FC Hex Handpiece Adapter-Long
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RS6195AModel TMA-FC Hex Handpiece Adapter
Identity
- Trade Name
- TMA/FC Hex Handpiece Adapter-Long EUDAMEDFDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Model / Reference
- TMA-FC Hex Handpiece Adapter EUDAMEDRS6195A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290105156228 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010515TMAHHandPAdapAE EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L0317 GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE EUDAMED
- GMDN Term
- Dental torque wrench FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
A comprehensive medical device directory listing the TMA/FC Hex Handpiece Adapter-Long, a sterile surgical handpiece for ENT procedures.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 729010515TMAHHandPAdapAE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Adin Dental Implant Systems LTD.
- EUDAMED SRN
- IL-MF-000014625
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 162fd8a0-b42f-41c2-a3e6-699b031bd5d4 61 fields · synced Oct 6, 2026
- FDA UDI 3136238a-507c-4d75-88ed-f8fb0e0012c0 32 fields · synced May 30, 2026