Identity
- Trade Name
- HephaBike EUDAMED
- Device Name
- NeuroSkin System EUDAMED
- Model / Reference
- HPBKSYS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08607000348747 EUDAMED
- Basic UDI-DI
- 86070003487-MMSYSTEM-7X EUDAMED
- EMDN Code
- Z12062703 CYCLING STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Functional electrical stimulation EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
HephaBike by 3F-Fit Fabricando Faber d.o.o. Beograd-Čukarica — Class IIa — 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-MMSYSTEM-7X | Class IIa | Active |
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Manufacturer
- Manufacturer
- 3F-Fit Fabricando Faber d.o.o. Beograd-Čukarica
- EUDAMED SRN
- RS-PR-000034427
Sources (1)
- EUDAMED 4044da31-bc63-4ca9-b412-8e65066d1c68 61 fields · synced Jul 13, 2026