Identity
- Trade Name
- Tru Driver Hand EUDAMED
- Device Name
- Dental Instrument (Driver) EUDAMED
- Model / Reference
- TDH-H1215 EUDAMEDTDH-TX10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800076417380 EUDAMED08800076474611 EUDAMED
- Basic UDI-DI
- 88000764DIRXA EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
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
Tru Driver Hand by TruAbutment Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000764DIRXA | Class I | Active |
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Manufacturer
- Manufacturer
- TruAbutment Inc.
- EUDAMED SRN
- US-MF-000043448
- Authorised Representative
- AeMi World e.K DE-AR-000007704
Sources (2)
- EUDAMED 290e64c2-5ef8-4cd7-8a09-f091cae3e60f 61 fields · synced Jul 12, 2026
- EUDAMED c4a13052-a922-4b92-9c61-f163e2703a09 61 fields · synced May 17, 2026