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Left Double Offset Broach Handle - Enztec
EUDAMEDClass I (EU MDR)
Ref 1080-0-1901
Identity
- Trade Name
- Left Double Offset Broach Handle - Enztec EUDAMED
- Device Name
- Broach Handles EUDAMED
- Model / Reference
- 1080-0-1901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421038411223 EUDAMED
- Basic UDI-DI
- 942102811GMN0002ZS EUDAMED
- Direct Marketing DI
- 09421038411223 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
Left Double Offset Broach Handle - 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 | 942102811GMN0002ZS | 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 55650f90-3ba3-4c76-a723-39291bb78c5b 61 fields · synced May 21, 2026