Identity
- Trade Name
- Heartway Medical Products Co., Ltd FDA UDI
- Generic Name
- Wheelchair, power-assisted, occupant-controlled, collapsible FDA UDI
- Device Name
- Power Wheelchair EUDAMED
- Model / Reference
- HP5 EUDAMEDFDA UDIHP1HD EUDAMEDP35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719871230268 EUDAMEDFDA UDI04719871232248 EUDAMED04719871233351 EUDAMED
- Basic UDI-DI
- 471987123PWZ5 EUDAMED
- Direct Marketing DI
- 04719871230268 EUDAMED04719871232248 EUDAMED04719871233351 EUDAMED
- FDA Product Code
- ITI FDA UDI
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
- GMDN Term
- Wheelchair, power-assisted, occupant-controlled, collapsible FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3860 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
Power Wheelchair by Heartway Medical Products Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 471987123PWZ5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Heartway Medical Products Co. Ltd
- EUDAMED SRN
- TW-MF-000003315
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 788f07ed-c5ae-410d-91db-9572cef87f3b 61 fields · synced Oct 6, 2026
- EUDAMED 699a1147-e19f-45f6-b4e5-180439c74b1a 61 fields · synced May 18, 2026
- EUDAMED 04ad741b-bdb4-42f1-b27a-94fc13d82d93 61 fields · synced May 18, 2026
- FDA UDI f0c0a50d-eda4-4f76-b719-22a778501c7f 32 fields · synced May 29, 2026