Identity
- Trade Name
- 4.0mm Hex Driver - U-joint EUDAMED
- Device Name
- Inserter EUDAMED
- Model / Reference
- 4200-5402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421028117487 EUDAMED
- Basic UDI-DI
- 942102811GMN001628 EUDAMED
- Direct Marketing DI
- 09421028117487 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
4.0mm Hex Driver - U-joint by Enztec Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant impactor, reusable.
- TRIAL COVERING INSERT Ø32 48 — groupe lépine · Class IIa
- MobiliT Cup — CORIN LTD · Class II
- R3 — Smith & Nephew, Inc. · Class II
- TRIAL COVERING INSERT Ø28 39 — groupe lépine · Class IIa
- MobiliT Cup — CORIN LTD · Class II
- KMEDIC — TELEFLEX INCORPORATED · Class I
- TRIAL COVER INSERT Ø28 36 — groupe lépine · Class IIa
- R3 — Smith & Nephew, Inc. · Class I
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 |
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 8fc43408-c864-48a5-81b0-f42e5ac78b31 61 fields · synced Jun 18, 2026