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Electric Wheelchair
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref YHWL-002Model YHW001-C、YHW001-D、YHW001-E、YHWL-002、YHWL-003
Identity
- Device Name
- Electric Wheelchair EUDAMED
- Model / Reference
- YHW001-C、YHW001-D、YHW001-E、YHWL-002、YHWL-003 EUDAMEDYHWL-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974665668520 EUDAMED
- Basic UDI-DI
- 697466566Y90WG EUDAMED
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Wheelchair by Yongkang Youha Electric Appliance 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 | K240331 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697466566Y90WG | Class I | Active |
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Manufacturer
- Manufacturer
- Yongkang Youha Electric Appliance Co., Ltd
- EUDAMED SRN
- CN-MF-000035946
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 3dd55ca3-2e29-41f5-a68a-5f0db790425c 61 fields · synced Jun 19, 2026
- FDA 510(k) K240331 1 fields · synced May 18, 2026