Identity
- Trade Name
- Offset Cup Impactor Anvil EUDAMED
- Device Name
- Minimally Invasive Hip (MIH) - Non-powered EUDAMED
- Model / Reference
- MIH-004-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421028110211 EUDAMED
- Basic UDI-DI
- 942102811GMN002223 EUDAMED
- Direct Marketing DI
- 09421028110211 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Offset Cup Impactor Anvil 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 | 942102811GMN002223 | 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 cd1e8a5f-7ef2-42ee-87c3-260bbf4d4555 61 fields · synced Jun 18, 2026