Identity
- Trade Name
- RODILLERA CERRADA RODISIL ; KNEE SUPPORT W/ FLEXIBLE HINGES EUDAMED
- Device Name
- Rodilleras elásticas EUDAMED
- Model / Reference
- 9104#78 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435491850179 EUDAMED
- Basic UDI-DI
- 84350259ORL20401PN EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
- Models / Variants
- Rodillera Cerrada Rodisil EUDAMEDKnee Support W/ Flexible Hinges 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
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
Rodillera Cerrada Rodisil +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 | 84350259ORL20401PN | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED 9569f500-5e40-47e1-959b-0b312cd4b6c2 61 fields · synced Jun 18, 2026