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DermaPlast ACTIVE Malleo Soft plus Size2
EUDAMEDClass I (EU MDR)
Ref 589052Model Ortesis para tobillo-pie
Identity
- Trade Name
- DermaPlast ACTIVE Malleo Soft plus Size2 EUDAMED
- Device Name
- Ortesis para tobillo-pie EUDAMED
- Model / Reference
- Ortesis para tobillo-pie EUDAMED589052 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436042059164 EUDAMED
- Basic UDI-DI
- 843604205dermalleosoftpJ4 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT 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 Malleo Soft plus Size2 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 | 843604205dermalleosoftpJ4 | Class I | Active |
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Manufacturer
- Manufacturer
- Shanae Servicios Geriatricos S.l.
- EUDAMED SRN
- ES-MF-000001503
Sources (1)
- EUDAMED 941421f2-2b45-4944-9366-50c932a53475 61 fields · synced Jun 18, 2026