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Offset Acetabular Shell Impactor - Enztec
EUDAMEDClass I (EU MDR)
Ref 1080-0-1701
Identity
- Trade Name
- Offset Acetabular Shell Impactor - Enztec EUDAMED
- Device Name
- Enztec Cup Impactors EUDAMED
- Model / Reference
- 1080-0-1701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421038411643 EUDAMED
- Basic UDI-DI
- 942102811GMN00092B EUDAMED
- Direct Marketing DI
- 09421038411643 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
Offset Acetabular Shell Impactor - Enztec 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 74a9d0e1-5a9c-404a-961f-a8ab79638062 61 fields · synced Jun 19, 2026