Identity
- Trade Name
- Amplitude Femoral Sizer EUDAMED
- Device Name
- Femoral Alignment Guides EUDAMED
- Model / Reference
- 4240-7070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421028110990 EUDAMED
- Basic UDI-DI
- 942102811GMN0012ZV EUDAMED
- Direct Marketing DI
- 09421028110990 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
Amplitude Femoral Sizer 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 | 942102811GMN0012ZV | 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 0d8f4875-2a51-49d9-8110-8cb0e11f7c1e 61 fields · synced Jun 18, 2026