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Electrically powered wheelchair
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref HP201Model HP358E、HP358EA、HP202、HP201、HP200、HP458E、EY07、EY18、P15、P55、HP203、HP204、HP205、HP206、HP207、HP208、HP209、HP210、HP211、HP212
Identity
- Device Name
- Electrically powered wheelchair EUDAMED
- Model / Reference
- HP358E、HP358EA、HP202、HP201、HP200、HP458E、EY07、EY18、P15、P55、HP203、HP204、HP205、HP206、HP207、HP208、HP209、HP210、HP211、HP212 EUDAMEDHP201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973852592013 EUDAMED
- Basic UDI-DI
- 697385259Ewheelchair95 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
Electrically powered wheelchair by Kunshan Hi-Fortune Health Products Co., Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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 | K201855 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697385259Ewheelchair95 | Class I | Active |
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Manufacturer
- Manufacturer
- Kunshan Hi-Fortune Health Products Co., Ltd
- EUDAMED SRN
- CN-MF-000035403
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED a994263e-815b-4d55-b56f-de1c1dac55ca 61 fields · synced Oct 7, 2026
- FDA 510(k) K201855 1 fields · synced May 18, 2026