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Frontier
EUDAMEDClass I (EU MDR)
Ref W3431Model W3331,W3431,W3431B,W3431D,W3433,W3433D W3433E,W3435,W3451,N3458,N3458A,N3458C W3459,W3463,W3463A,W3467,N3473,W3901 W3465,W3481,N3473A,N3473C,W3902(S50 Carbon) W3431Q,W3431T,W3483,W3483A,W3483B,W3458G，W3431M,W3431U,W3489,W3470A,W3470B
Identity
- Trade Name
- Frontier EUDAMED
- Device Name
- Mobility Scooter EUDAMED
- Model / Reference
- W3331,W3431,W3431B,W3431D,W3433,W3433D W3433E,W3435,W3451,N3458,N3458A,N3458C W3459,W3463,W3463A,W3467,N3473,W3901 W3465,W3481,N3473A,N3473C,W3902(S50 Carbon) W3431Q,W3431T,W3483,W3483A,W3483B,W3458G，W3431M,W3431U,W3489,W3470A,W3470B EUDAMEDW3431 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978949462033 EUDAMED
- Basic UDI-DI
- 697894946MS001W6 EUDAMED
- EMDN Code
- Y122124 ELECTRIC SCOOTERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Frontier by Zhejiang Innuovo Rehabilitation Devices Co., Ltd. — 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 | 697894946MS001W6 | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000008727
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6e6510d6-257b-4c50-8ccc-9acd63eb7517 61 fields · synced Jul 18, 2026