Identity
- Trade Name
- PANTALON NEOPRENO ALTO ; HIGH NEOPRENE PANTS EUDAMED
- Device Name
- O.T Elástica (Pantalón/ortesis cintura) EUDAMED
- Model / Reference
- 4701#E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435025908178 EUDAMED
- Basic UDI-DI
- 84350259ORL20203PG EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
- Models / Variants
- Pantalon Neopreno Alto EUDAMEDHigh Neoprene Pants 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
Pantalon Neopreno Alto +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 | 84350259ORL20203PG | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED d1152d41-7281-4d0b-bdbb-4ad667a83cce 61 fields · synced Jul 11, 2026