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DermaPlast ACTIVE Epi Soft S
EUDAMEDClass I (EU MDR)
Ref 589001Model EPI SOFTModel Epi Soft
Identity
- Trade Name
- DermaPlast ACTIVE Epi Soft S EUDAMED
- Device Name
- EPI SOFT EUDAMED
- Model / Reference
- EPI SOFT EUDAMED589001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436042058952 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 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 | 843604205dermaepisoftUT | Class I | Active |
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Manufacturer
- Manufacturer
- Shanae Servicios Geriatricos S.l.
- EUDAMED SRN
- ES-MF-000001503
Sources (2)
- EUDAMED 706526d4-0cb2-4c60-8638-73bc42ab2bbb 61 fields · synced Oct 6, 2026
- EUDAMED bb1bb66a-77df-42a9-8e41-aa342d066006 61 fields · synced Jul 21, 2026