Identity
- Trade Name
- ORTESIS DE TOBILLO ESTÁNDAR ; ANKLE BRACE EUDAMED
- Device Name
- Ortesis de tobillo - Estabilizadoras/Articuladas EUDAMED
- Model / Reference
- ACV901#2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435491812085 EUDAMED
- Basic UDI-DI
- 84350259ORL20406PY EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
- Models / Variants
- Ortesis De Tobillo Estándar EUDAMEDAnkle Brace 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
Category: Ankle/foot orthosis
ORTESIS DE TOBILLO ESTÁNDAR - Ankle Brace by Orliman, S.L.U. — Class I — MDR — listed in EUDAMED — 2 models — regulatory data on deviCERTS
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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 ef1a2bf3-823c-450a-a100-4accbc8b1005 61 fields · synced Jul 9, 2026