Identity
- Trade Name
- BRACE DE HUMERO COMBINADO ; HUMERUS BRACE THERMOPLASTIC LINED EUDAMED
- Device Name
- Muñequera Inmovilizadora EUDAMED
- Model / Reference
- TP-6401#E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435025980037 EUDAMED
- Basic UDI-DI
- 84350259ORL20304PP EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
- Models / Variants
- Brace De Humero Combinado 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
Brace De Humero Combinado +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 | 84350259ORL20304PP | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED a9045b88-1eb6-4d26-8870-63848b2753c3 61 fields · synced Jun 14, 2026