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Tbfix Rack
EUDAMEDClass I (EU MDR)
Ref OTA CR026Model Class I InstrumentRef OTA CR014
Identity
- Trade Name
- TBFIX RACK EUDAMED
- Device Name
- Class I Instrument EUDAMED
- Model / Reference
- Class I Instrument EUDAMEDOTA CR026 EUDAMEDOTA CR014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483OTACR0260 EUDAMED+M483OTACR0140 EUDAMED
- Basic UDI-DI
- ++M483L0999ZW EUDAMED
- Direct Marketing DI
- +M483OTACR0260 EUDAMED+M483OTACR0140 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY 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
Tbfix Rack 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 | ++M483L0999ZW | Class I | Active |
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Manufacturer
- Manufacturer
- groupe lépine
- EUDAMED SRN
- FR-MF-000001182
Sources (2)
- EUDAMED 2f0cfdf9-52fc-4962-b517-2e6198ce7011 61 fields · synced Sep 18, 2026
- EUDAMED 237ca74b-0d96-4c4b-991f-ce30288db558 61 fields · synced May 18, 2026