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Adjustable Tibial Stylus
EUDAMEDClass I (EU MDR)
Ref GKAPR001Model Class Ir Instrument
Identity
- Trade Name
- ADJUSTABLE TIBIAL STYLUS EUDAMED
- Device Name
- Class Ir Instrument EUDAMED
- Model / Reference
- Class Ir Instrument EUDAMEDGKAPR001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483GKAPR0010 EUDAMED
- Basic UDI-DI
- ++M483L0909Z3 EUDAMED
- Direct Marketing DI
- +M483GKAPR0010 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
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
Adjustable Tibial Stylus 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 25769e38-e2ab-4f0d-b71c-bcf09965844c 61 fields · synced Jun 18, 2026