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DermaPlast ACTIVE Genu Soft S
EUDAMEDClass I (EU MDR)
Ref 589011Model GENU SOFT
Identity
- Trade Name
- DermaPlast ACTIVE Genu Soft S EUDAMED
- Device Name
- Ortesis de Rodilla EUDAMEDGENU SOFT EUDAMED
- Model / Reference
- 589011 EUDAMEDGENU SOFT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436042058983 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 S 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 (2)
- EUDAMED 02bbb240-e77e-43d9-a22f-a8b41e531c3c 61 fields · synced Oct 6, 2026
- EUDAMED f0833c6f-7e0c-44e6-b1d5-874f89d59ae0 61 fields · synced Jul 11, 2026