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Support Bloc Intra Tibial
EUDAMEDClass I (EU MDR)
Ref GKAVS004Model Class Ir Instrument
Identity
- Trade Name
- SUPPORT BLOC INTRA TIBIAL EUDAMED
- Device Name
- Class Ir Instrument EUDAMED
- Model / Reference
- Class Ir Instrument EUDAMEDGKAVS004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483GKAVS0040 EUDAMED
- Basic UDI-DI
- ++M483L0909Z3 EUDAMED
- Direct Marketing DI
- +M483GKAVS0040 EUDAMED
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Support Bloc Intra Tibial by groupe lépine — 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 | ++M483L0909Z3 | Class I | Active |
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Manufacturer
- Manufacturer
- groupe lépine
- EUDAMED SRN
- FR-MF-000001182
Sources (1)
- EUDAMED 55cb61f3-844e-4359-a853-862ea1e1e0b8 61 fields · synced Jul 13, 2026