Identity
- Trade Name
- Std ACL Bullet Guide 4.5mm EUDAMED
- Device Name
- Drill Guides EUDAMED
- Model / Reference
- 35130495 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421028115254 EUDAMED
- Basic UDI-DI
- 942102811GMN000829 EUDAMED
- Direct Marketing DI
- 09421028115254 EUDAMED
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
Classification
- Device Class
- Class I 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
Std ACL Bullet Guide 4.5mm 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 | 942102811GMN000829 | 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 d97eef6f-c76b-4653-b3fc-760b995bb1ed 61 fields · synced Jun 17, 2026