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Electric wheelchairs
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref DH01101Model DH01101\DH01102\DH01103\DH01105\DH01106\DH01107\DH01108\DH01109\DH01111\DH01112\DH01113\DH01114\DH01117\DH01120\DH01121\DH01122\DH01123\DH01125\DH01152\DH01124(XA5)\DH01168510(k) K220827
Identity
- Device Name
- Electric wheelchairs EUDAMED
- Model / Reference
- DH01101\DH01102\DH01103\DH01105\DH01106\DH01107\DH01108\DH01109\DH01111\DH01112\DH01113\DH01114\DH01117\DH01120\DH01121\DH01122\DH01123\DH01125\DH01152\DH01124(XA5)\DH01168 EUDAMEDDH01101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973717271527 EUDAMED
- Basic UDI-DI
- 697371727DHEW001RK EUDAMED
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 wheelchairs by Foshan Dahao Medical Technology 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
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 | K253307 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K220827 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697371727DHEW001RK | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Dahao Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035947
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 52001ddd-d958-47ba-b071-e830361d6a8b 85 fields · synced Jun 18, 2026
- FDA 510(k) K253307 1 fields · synced May 18, 2026