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Electric Wheelchair
EUDAMEDClass I (EU MDR)
Ref BC-EA5518Model 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
- 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-EA5518 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975185620456 EUDAMED
- Basic UDI-DI
- 697518562ewheelchair001YK 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 Wheelchair by Ningbo Baichen Medical Devices Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED 6973015f-986c-421e-a194-605ab37b2cd2 61 fields · synced Jun 18, 2026