Identity
- Trade Name
- 3.5mm Hex Driver EUDAMED3.5mm Hex Driver - U-joint EUDAMED
- Device Name
- Inserter EUDAMED
- Model / Reference
- 4200-5351 EUDAMED4200-5352 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421028117463 EUDAMED09421028117470 EUDAMED
- Basic UDI-DI
- 942102811GMN001628 EUDAMED
- Direct Marketing DI
- 09421028117463 EUDAMED09421028117470 EUDAMED
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I 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
Category: Orthopaedic implant impactor, reusable
3.5mm Hex Driver by Enztec Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 942102811GMN001628 | Class I | Active |
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Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 8bd16603-6094-410f-aac5-263bd22b5025 61 fields · synced Sep 18, 2026
- EUDAMED 6d1e26b1-d917-44af-858b-9e3558cc9ae7 61 fields · synced May 18, 2026