Identity
- Trade Name
- DermaPlast® ACTIVE Genu Soft M EUDAMED
- Device Name
- Ortesis de Rodilla EUDAMED
- Model / Reference
- 589012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436042058990 EUDAMED
- Basic UDI-DI
- 843604205dermagenusoft4D EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I 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
DermaPlast® ACTIVE Genu Soft M by Shanae Servicios Geriatricos S.l. — Class I — MDR — listed in EUDAMED — 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 | 843604205dermagenusoft4D | Class I | Active |
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Manufacturer
- Manufacturer
- Shanae Servicios Geriatricos S.l.
- EUDAMED SRN
- ES-MF-000001503
Sources (1)
- EUDAMED 6ab6fd16-922c-4fc1-a1e2-05be39c9b797 61 fields · synced Jun 17, 2026