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1.27 Hex Driver for Handpiece - Long
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RS9035Model Hex Driver for Handpiece
Identity
- Trade Name
- 1.27 Hex Driver for Handpiece - Long EUDAMEDFDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Model / Reference
- Hex Driver for Handpiece EUDAMEDRS9035 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290105156891 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010515HexDrivHandP7V EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, 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
Category: Surgical screwdriver, reusable
1.27 Hex Driver for Handpiece - Long by Adin Dental Implant Systems Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Surgical screwdriver, reusable.
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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 | 729010515HexDrivHandP7V | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Adin Dental Implant Systems LTD.
- EUDAMED SRN
- IL-MF-000014625
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 2366a0e0-1a84-45ee-8ad4-bd6d2cd66a82 61 fields · synced Jul 12, 2026
- FDA UDI 7a42ab63-0f32-4b97-b862-233bef3ec278 32 fields · synced May 30, 2026