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Electrically powered wheelchair
EUDAMEDFDA UDIClass I (EU MDR)
Ref HP358EAModel HP358E、HP358EA、HP202、HP201、HP200、HP458E、EY07、EY18、P15、P55、HP203、HP204、HP205、HP206、HP207、HP208、HP209、HP210、HP211、HP212
Identity
- Trade Name
- Hi-Fortune FDA UDI
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
- 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 EUDAMEDHP358EA EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973852593591 EUDAMED06973852592068 FDA UDI
- Basic UDI-DI
- 697385259Ewheelchair95 EUDAMED
- 510(k) Number
- K211647 FDA UDI
- FDA Product Code
- ITI FDA UDI
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
- GMDN Term
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3860 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Electrically powered wheelchair by Kunshan Hi-Fortune Health Products Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697385259Ewheelchair95 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 eeb1a20d-a5f2-45aa-aed5-5355f57d2d71 61 fields · synced Oct 6, 2026
- FDA UDI 7563e0cb-455c-4c90-ba45-71002cb1b2f7 33 fields · synced May 30, 2026