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DermaPlast ACTIVE Malleo Soft plus Size1
EUDAMEDClass I (EU MDR)
Ref 589051Model Ortesis para tobillo-pieModel MALLEO SOFT PLUS
Identity
- Trade Name
- DermaPlast ACTIVE Malleo Soft plus Size1 EUDAMED
- Device Name
- Ortesis para tobillo-pie EUDAMEDMALLEO SOFT PLUS EUDAMED
- Model / Reference
- Ortesis para tobillo-pie EUDAMED589051 EUDAMEDMALLEO SOFT PLUS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436042059157 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
Category: Ankle/foot orthosis
DermaPlast ACTIVE Malleo Soft plus Size1 by Shanae Servicios Geriatricos S.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (2)
- EUDAMED 1aada646-eb9d-4c04-a768-612c92c5e1c4 61 fields · synced Jun 19, 2026
- EUDAMED b8df4bbf-8920-40e1-9f0b-eeed84092df0 61 fields · synced Jun 19, 2026