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Trephine Vis Canula Ø3.5
EUDAMEDClass IIa (EU MDR)
Ref OCA TA035Model Orthopaedic implant instruments, single use - other
Identity
- Trade Name
- TREPHINE VIS CANULA Ø3.5 EUDAMED
- Device Name
- Orthopaedic implant instruments, single use - other EUDAMED
- Model / Reference
- Orthopaedic implant instruments, single use - other EUDAMEDOCA TA035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483OCATA0350 EUDAMED
- Basic UDI-DI
- ++M483P091399JU EUDAMED
- Direct Marketing DI
- +M483OCATA0350 EUDAMED
- EMDN Code
- P091301 ORTHOPAEDIC IMPLANT REAMERS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
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
Trephine Vis Canula Ø3.5 by groupe lépine — 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 | ++M483P091399JU | Class IIa | Active |
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Manufacturer
- Manufacturer
- groupe lépine
- EUDAMED SRN
- FR-MF-000001182
Sources (1)
- EUDAMED a339f78c-f4b5-4a58-8f42-864d7e7d2db3 61 fields · synced Jun 18, 2026