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Electrically powered wheelchair
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref KZ301BModel KZ301B KZ301A
Identity
- Device Name
- Electrically powered wheelchair EUDAMED
- Model / Reference
- KZ301B KZ301A EUDAMEDKZ301B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972665813995 EUDAMED
- Basic UDI-DI
- 697266581PWheelchairN6 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
Electrically powered wheelchair by Nanjing Kangni Smart Technology 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 | K252494 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697266581PWheelchairN6 | Class I | Active |
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Manufacturer
- Manufacturer
- Nanjing Kangni Smart Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000012186
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 3a0abd1f-6d91-472e-8a5a-88880b171ea5 61 fields · synced Jun 19, 2026
- FDA 510(k) K252494 1 fields · synced May 18, 2026