Power Wheelchair
by Zhejiang Innuovo Rehabilitation Devices Co., Ltd. 20 variants
Ref W5536Model 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, N5513A,N5515,N5515A,N5516,N5516A,N5516C,W5517,N5517A,N5519,W5521,W5521B,N5525,W5526,W5536,W5536A,W5536B,W5538,N5901,W5905,W5905A,W5907,Q50R Carbon,N5909,N5909A,W5211,W5211B,W5213,W5213C,W5216,N5909D,W5915B,W5915C,W5915D,N5919,N5516D,N5516E,N5516F
Active
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697894946MS001W6 | Date8 Aug 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Mobility Scooter
- 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, W5536, N5513A, N5515, N5515A, N5516, N5516A, N5516C, W5517, N5517A, N5519, W5521, W5521B, N5525, W5526, W5536A, W5536B, W5538, N5901, W5905, W5905A, W5907, Q50R Carbon, N5909, N5909A, W5211, W5211B, W5213, W5213C, W5216, N5909D, W5915B, W5915C, W5915D, N5919, N5516D, N5516E, N5516F
- Primary DI / UDI-DI
- 06978949461746, 06978949462989
- Basic UDI-DI
- 697894946MS001W6, 697894946PW001Y3
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000008727
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
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Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No