Identity
- Trade Name
- DermaPlast ACTIVE Epi Soft L EUDAMED
- Device Name
- EPI SOFT EUDAMED
- Model / Reference
- EPI SOFT EUDAMED589003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436042058976 EUDAMED
- Basic UDI-DI
- 843604205dermaepisoftUT EUDAMED
- EMDN Code
- Y060615 ELBOW 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 Epi Soft L 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 | 843604205dermaepisoftUT | Class I | Active |
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Manufacturer
- Manufacturer
- Shanae Servicios Geriatricos S.l.
- EUDAMED SRN
- ES-MF-000001503
Sources (1)
- EUDAMED dd05900f-2415-4921-8a86-5220000bf99e 61 fields · synced Jun 18, 2026