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Electric Wheelchair
EUDAMEDFDA UDIClass I (EU MDR)
Ref BC-EA8000Model 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
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-EA8000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975185620005 EUDAMEDFDA UDI
- Basic UDI-DI
- 697518562ewheelchair001YK EUDAMED
- 510(k) Number
- K232121 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 — 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 | 697518562ewheelchair001YK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 7bfa0c51-80fa-4e65-95ef-0b0876785cbf 61 fields · synced Jul 12, 2026
- FDA UDI 106f46be-a8b3-4881-ba03-aadda031c4fc 33 fields · synced May 29, 2026