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Rotax Trial Tibial Extractor
EUDAMEDClass I (EU MDR)
Ref GRAET001Model Class Ir Instrument
Identity
- Trade Name
- ROTAX TRIAL TIBIAL EXTRACTOR EUDAMED
- Device Name
- Class Ir Instrument EUDAMED
- Model / Reference
- Class Ir Instrument EUDAMEDGRAET001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483GRAET0010 EUDAMED
- Basic UDI-DI
- ++M483L0911YN EUDAMED
- Direct Marketing DI
- +M483GRAET0010 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS 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
Rotax Trial Tibial Extractor 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 | ++M483L0911YN | Class I | Active |
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Manufacturer
- Manufacturer
- groupe lépine
- EUDAMED SRN
- FR-MF-000001182
Sources (1)
- EUDAMED 5634862c-5951-414f-9671-1aa6d7185214 61 fields · synced Jul 24, 2026