Identity
- Device Name
- Power Wheelchair EUDAMED
- Model / Reference
- HP8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719871230121 EUDAMED
- Basic UDI-DI
- 471987123PWZ5 EUDAMED
- Direct Marketing DI
- 04719871230121 EUDAMED
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Power Wheelchair by Heartway Medical Products 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 | K132856 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 471987123PWZ5 | Class I | Active |
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Manufacturer
- Manufacturer
- Heartway Medical Products Co. Ltd
- EUDAMED SRN
- TW-MF-000003315
- FDA Applicant
- Heartway Medical Products Co., Ltd.
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 1fb114b6-fa65-441e-9666-c926ef439c2f 85 fields · synced Jun 18, 2026
- FDA 510(k) K132856 1 fields · synced May 18, 2026