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Power Wheelchair
EUDAMEDClass I (EU MDR)
Ref W5905Model N5513,N5513A,N5515,N5515A,N5516,N5516A, N5516C,W5517,N5517A,N5519,W5521,W5521B, N5525,W5526,W5536,W5536A,W5536B,W5538, W5538D,N5901,W5905,W5905A,W5907, Q50 R Carbon,N5909,N5909A,W5211,W5211B, W5213,W5213C,W5216,W5217,N5909D,W5915B, W5915C,W5915D,N5919Ref W5213Ref N5901Ref W5211Ref W5536BRef W5536ARef N5516Ref N5517ARef N5525Ref 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
Identity
- Trade Name
- Power Wheelchair EUDAMED
- Device Name
- Power Wheelchair EUDAMEDMobility Scooter EUDAMED
- Model / Reference
- N5513,N5513A,N5515,N5515A,N5516,N5516A, N5516C,W5517,N5517A,N5519,W5521,W5521B, N5525,W5526,W5536,W5536A,W5536B,W5538, W5538D,N5901,W5905,W5905A,W5907, Q50 R Carbon,N5909,N5909A,W5211,W5211B, W5213,W5213C,W5216,W5217,N5909D,W5915B, W5915C,W5915D,N5919 EUDAMEDW5905 EUDAMEDW5213 EUDAMEDN5901 EUDAMEDW5211 EUDAMEDW5536B EUDAMEDW5536A EUDAMEDN5516 EUDAMEDN5517A EUDAMEDN5525 EUDAMEDW3331,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 EUDAMEDW5536 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978949462279 EUDAMED06978949462316 EUDAMED06978949462439 EUDAMED06978949461722 EUDAMED06978949462996 EUDAMED06978949462811 EUDAMED06978949462774 EUDAMED06978949462972 EUDAMED06978949461906 EUDAMED06978949461746 EUDAMED06978949461678 EUDAMED
- Basic UDI-DI
- 697894946PW001Y3 EUDAMED697894946MS001W6 EUDAMED
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDSpain 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
Yes
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Power Wheelchair 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 | 697894946PW001Y3 | 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 (11)
- EUDAMED c143ecf2-4298-427a-9053-81084a549eca 61 fields · synced Jul 30, 2026
- EUDAMED 406e1189-a3e6-490e-a0ff-ce1acc0b1ed0 61 fields · synced May 18, 2026
- EUDAMED 88ae0746-1950-46a9-bdd1-24d4fdc84d5c 61 fields · synced May 18, 2026
- EUDAMED d24dcdb2-98a1-4c6f-87d6-74d0ee27e633 61 fields · synced Jul 11, 2026
- EUDAMED dcac9e11-6ba2-471f-bf99-4e358b330c92 61 fields · synced Jul 11, 2026
- EUDAMED cc8a74b6-f44b-4218-a90a-c81891f81abe 61 fields · synced Jul 14, 2026
- EUDAMED ccab61ec-7aa8-4cdb-8848-416e405559be 61 fields · synced Jul 15, 2026
- EUDAMED 5dc8269d-af8f-41fc-8c66-1a83bd056c87 61 fields · synced Jul 17, 2026
- EUDAMED 24b94ba6-a994-4885-aa2f-80b113478875 61 fields · synced Jul 17, 2026
- EUDAMED 832201dc-6681-4c09-9431-1895e4250043 61 fields · synced Jul 19, 2026
- EUDAMED 2d70b27c-0221-48b1-af67-249dbfbfc279 61 fields · synced Jul 26, 2026