Identity
- Trade Name
- Offset drive train, open EUDAMED
- Device Name
- Reamer Drivers and Acetabular Reamers EUDAMED
- Model / Reference
- 9209-1304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421038412329 EUDAMED
- Basic UDI-DI
- 942102811GMN003022 EUDAMED
- Direct Marketing DI
- 09421038412329 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Offset drive train, open by Enztec Limited — Class IIa — 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 | 942102811GMN003022 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED e9197f62-b608-4f2e-8f9e-4c53ed329885 61 fields · synced Jul 22, 2026