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Tobillera Estabilizadora Fixquick T.4 M: 29 - 32 +1 more model
EUDAMEDClass I (EU MDR)
Ref BCS900#4
Identity
- Trade Name
- TOBILLERA ESTABILIZADORA FIXQUICK T.4 M: 29 - 32 ; STABILISING ANKLE BRACE - FIXQUICK EUDAMED
- Device Name
- Ortesis de tobillo - Estabilizadoras/Articuladas EUDAMED
- Model / Reference
- BCS900#4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435491814966 EUDAMED
- Basic UDI-DI
- 84350259ORL20406PY EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
- Models / Variants
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Tobillera Estabilizadora Fixquick T.4 M: 29 - 32 +1 more model by Orliman, S.L.U. — Class I — MDR — listed in EUDAMED — 2 models — 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 | 84350259ORL20406PY | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED 649f0aff-95ca-420e-8efb-0e6305810696 61 fields · synced Jul 13, 2026