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Accesorio Protector Tibial T.uni +1 more model
EUDAMEDClass I (EU MDR)
Ref TP-4801#UNI
Identity
- Trade Name
- ACCESORIO PROTECTOR TIBIAL T.UNI ; THERMOPLASTIC TIBIAL ACCESSORY EUDAMED
- Device Name
- Ortesis de pantorrilla - Elásticas EUDAMED
- Model / Reference
- TP-4801#UNI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435025979659 EUDAMED
- Basic UDI-DI
- 84350259ORL20412PT EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
- Models / Variants
- Accesorio Protector Tibial T.uni EUDAMEDThermoplastic Tibial Accessory EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Accesorio Protector Tibial T.uni +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 | 84350259ORL20412PT | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED a90fe077-c1ad-49cf-8e8f-36b44862f9bb 61 fields · synced Jun 19, 2026