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Expanding Impaction Handle DM Cup - Handle
EUDAMEDClass I (EU MDR)
Ref 75.48.252
Identity
- Trade Name
- Expanding Impaction Handle DM Cup - Handle EUDAMED
- Device Name
- Enztec Cup Impactors EUDAMED
- Model / Reference
- 75.48.252 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421028114035 EUDAMED
- Basic UDI-DI
- 942102811GMN00092B EUDAMED
- Direct Marketing DI
- 09421028114035 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER 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
Expanding Impaction Handle DM Cup - Handle 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 | 942102811GMN00092B | 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 20fe7b25-11fd-4aec-b952-9c7089be892e 61 fields · synced Jun 18, 2026