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Electric Wheelchair
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref BC-EC8002Model BC-EA8000; BC-EA7001; BC-EA8001; BC-EA8002; BC-EA8003; BC-EA8004; BC-EA8005; BC-EA8006; BC-EA8007; BC-EA8008; BC-EA8009; BC-EA8010; BC-EA9000; BC-EA5521; BC-EC01;BC-EC02;BC-EA5515; BC-EA530; BC-EA5513; BC-EALD3; BC-ES6001; BC-ES6003,etcRef BC-EA8001
Identity
- Trade Name
- Baichen FDA UDI
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
- Device Name
- Electric Wheelchair EUDAMED
- Model / Reference
- BC-EA8000; BC-EA7001; BC-EA8001; BC-EA8002; BC-EA8003; BC-EA8004; BC-EA8005; BC-EA8006; BC-EA8007; BC-EA8008; BC-EA8009; BC-EA8010; BC-EA9000; BC-EA5521; BC-EC01;BC-EC02;BC-EA5515; BC-EA530; BC-EA5513; BC-EALD3; BC-ES6001; BC-ES6003,etc EUDAMEDBC-EC8002 EUDAMEDFDA UDIBC-EA8001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975185620289 EUDAMED06975185620029 EUDAMEDFDA UDI
- Basic UDI-DI
- 697518562ewheelchair001YK EUDAMED
- 510(k) Number
- K250475 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
- Austria 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Electric Wheelchair by Ningbo Baichen Medical Devices Co., Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K250475 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697518562ewheelchair001YK | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Baichen Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000021409
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED e4aec782-7a3b-424b-a129-bf59d49aad1d 61 fields · synced Jul 16, 2026
- EUDAMED 6df7b2a1-ac56-4fc3-8847-f3e340b807a6 61 fields · synced May 19, 2026
- FDA UDI 93d6726b-3b4e-4ed6-baae-c3afc61fb20c 33 fields · synced May 29, 2026
- FDA 510(k) K250475 1 fields · synced May 18, 2026