Identity
- Trade Name
- RODILLERA GENU-UP SOFT; KNEE GENU-UP SOFT EUDAMED
- Device Name
- Rodilleras estabilizadoras/articuladas EUDAMED
- Model / Reference
- GR100#E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435491844109 EUDAMED
- Basic UDI-DI
- 84350259ORL20403PS EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
- Models / Variants
- Rodillera Genu-Up Soft EUDAMEDKnee Genu-Up Soft 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
Rodillera Genu-Up Soft +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 | 84350259ORL20403PS | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED 78a009c7-3e6b-4f09-b53c-375a597a65d5 61 fields · synced Jul 8, 2026