Identity
- Trade Name
- KNEO Femoral Impactor Head EUDAMEDKNEO Femoral Impactor EUDAMED
- Device Name
- Enztec Femoral Impactors EUDAMED
- Model / Reference
- 4240-3087 EUDAMED4240-3086 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421028116145 EUDAMED09421028116138 EUDAMED
- Basic UDI-DI
- 942102811GMN0010ZR EUDAMED
- Direct Marketing DI
- 09421028116145 EUDAMED09421028116138 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
KNEO Femoral Impactor Head 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 | 942102811GMN0010ZR | 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 95ce28d7-482b-45c9-95d6-40448dab7962 61 fields · synced Jul 11, 2026
- EUDAMED a01c9c40-c99d-4c4e-909c-7396c098dd69 61 fields · synced May 18, 2026