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Electric wheelchairs
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref W-A810Ref W-A807Model W-A802, W-A803, W-A804, W-A805, W-A806, W-A807, W-A808, W-A809, W-A810, W-A811510(k) K253599Ref W-A811Ref W-A806Ref W-A804Ref W-A805Ref W-A809Ref W-A803
Identity
- Device Name
- Electric wheelchairs EUDAMED
- Model / Reference
- W-A810 EUDAMEDW-A802, W-A803, W-A804, W-A805, W-A806, W-A807, W-A808, W-A809, W-A810, W-A811 EUDAMEDW-A807 EUDAMEDW-A811 EUDAMEDW-A806 EUDAMEDW-A804 EUDAMEDW-A805 EUDAMEDW-A809 EUDAMEDW-A803 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950572845100 EUDAMED06950572845070 EUDAMED06950572845117 EUDAMED06950572845063 EUDAMED06950572843045 EUDAMED06950572843052 EUDAMED06950572845094 EUDAMED06950572843021 EUDAMED
- Basic UDI-DI
- 695057284510JJ EUDAMED695057284507JV EUDAMED695057284511JL EUDAMED695057284506JT EUDAMED695057284304JD EUDAMED695057284305JF EUDAMED695057284509JZ EUDAMED695057284302J9 EUDAMED
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS 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
Electric wheelchairs by Ningbo Shenyu Medical Equipment Co., Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253599 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 695057284510JJ | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Shenyu Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000003330
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (9)
- EUDAMED 857e7320-2fd5-4df8-af32-bc37c1907988 61 fields · synced Oct 7, 2026
- EUDAMED db52fc3f-96b5-4fd1-95b2-ba76dfaf96da 85 fields · synced May 17, 2026
- EUDAMED 9f413afa-3f2c-4c03-bbc3-6ac593eecb94 61 fields · synced May 17, 2026
- EUDAMED e5f6f5e6-fab4-4175-b207-3497a3d66917 61 fields · synced Jun 18, 2026
- EUDAMED 64b60492-c83b-477a-a7d4-1326cfc06536 61 fields · synced Jul 10, 2026
- EUDAMED ce4384bb-cf60-4443-9d8d-0e8d6d03cd9e 61 fields · synced Jul 16, 2026
- EUDAMED fcc82e9b-0473-4b06-9f14-b0a7fbe299fc 61 fields · synced Jul 20, 2026
- EUDAMED ff103063-0d5d-441e-b95d-aee733663d65 61 fields · synced Jul 29, 2026
- FDA 510(k) K253599 1 fields · synced May 18, 2026