Identity
- Trade Name
- Torque Indicating Handle 4Nm - AO EUDAMED
- Device Name
- Orthopaedic Handles EUDAMED
- Model / Reference
- 4200-5004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421028117586 EUDAMED
- Basic UDI-DI
- 942102811GMN002427 EUDAMED
- Direct Marketing DI
- 09421028117586 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER 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
Torque Indicating Handle 4Nm - AO by Enztec Limited — 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 | 942102811GMN002427 | Class I | Active |
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Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 71c1a919-fffa-4cc6-bf28-d03407612d04 61 fields · synced Jun 11, 2026