Identity
- Trade Name
- 4.5mm ACL Bullet EUDAMED4.5mm ACL Bullet with Shaft Marking EUDAMED
- Device Name
- Drill Guides EUDAMED
- Model / Reference
- 35130404 EUDAMED35130879 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421028115247 EUDAMED09421028119511 EUDAMED
- Basic UDI-DI
- 942102811GMN000829 EUDAMED
- Direct Marketing DI
- 09421028115247 EUDAMED09421028119511 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
4.5mm ACL Bullet 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 |
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Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 2fd2d743-1f82-424f-a1eb-a620c90e307d 61 fields · synced Jul 14, 2026
- EUDAMED 2bde6ca8-cfce-48b6-a862-2b3e69b0edd8 61 fields · synced May 17, 2026