Identity
- Trade Name
- Neuroskin Insoles EUDAMED
- Device Name
- NeuroSkin EUDAMED
- Model / Reference
- NeuroSkin EUDAMEDNSI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08607000348778 EUDAMED
- Basic UDI-DI
- 86070003487-NEUROSKIN-ZH EUDAMED
- EMDN Code
- Z12062780 FUNCTIONAL ELECTRICAL STIMULATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Neuroskin Insoles by 3F-Fit Fabricando Faber d.o.o. Beograd-Čukarica — 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 | 86070003487-NEUROSKIN-ZH | Class I | Active |
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Manufacturer
- Manufacturer
- 3F-Fit Fabricando Faber d.o.o. Beograd-Čukarica
- EUDAMED SRN
- RS-MF-000020496
- Authorised Representative
- Salus Cons Kft. HU-AR-000006177
Sources (1)
- EUDAMED 106d8616-73d5-47fa-a38d-baf32a2dc77f 61 fields · synced Oct 6, 2026