Identity
- Trade Name
- 3.5mm Hex Driver Shaft - AO - 100mm EUDAMED
- Device Name
- Surgical Power Tool Attachments EUDAMED
- Model / Reference
- 4200-5355 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421038410912 EUDAMED
- Basic UDI-DI
- 942102811GMN00282F EUDAMED
- Direct Marketing DI
- 09421038410912 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
3.5mm Hex Driver Shaft - AO - 100mm 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 | 942102811GMN00282F | Class IIa | Active |
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Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED de52ec7a-fe3a-43c2-a879-de8b903a58d6 61 fields · synced Jun 20, 2026