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Offset Drive Train - Locking - Crossbar - Shalby
EUDAMEDClass IIa (EU MDR)
Ref 1080-0-2601
Identity
- Trade Name
- Offset Drive Train - Locking - Crossbar - Shalby EUDAMED
- Device Name
- Reamer Drivers and Acetabular Reamers EUDAMED
- Model / Reference
- 1080-0-2601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421038411766 EUDAMED
- Basic UDI-DI
- 942102811GMN003022 EUDAMED
- Direct Marketing DI
- 09421038411766 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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 Drive Train - Locking - Crossbar - Shalby by Enztec Limited — Class IIa — 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 | 942102811GMN003022 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED f73f6a33-c518-457a-9ae1-e5d100b867d7 61 fields · synced Jul 20, 2026