Identity
- Trade Name
- Threaded Steinman Pin EUDAMEDThreaded Steinman Pin 5-40 UNC-2A X 160 EUDAMED
- Device Name
- Fixation Pins EUDAMED
- Model / Reference
- 4040-0002 EUDAMED35-4040-0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421028117050 EUDAMED09421028117036 EUDAMED
- Basic UDI-DI
- 942102811GMN001322 EUDAMED
- Direct Marketing DI
- 09421028112710 EUDAMED09421028112697 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Threaded Steinman Pin 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 | 942102811GMN001322 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 4ae553e5-44e8-4a9d-b7d9-727f984660d6 61 fields · synced Aug 2, 2026
- EUDAMED 2bc4035e-eb65-413c-8c76-b38e9d843543 61 fields · synced May 19, 2026