FDA Registration
Active
🇨🇳 China
NINGBO BAICHEN MEDICAL DEVICES CO., LTD
Reg #: 3019842343
·
FEI: 3019842343
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- NINGBO BAICHEN MEDICAL DEVICES CO., LTD
- Registration Number
- 3019842343
- FEI Number
- 3019842343
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 2101, No.666 Taikang Middle Road, Yinzhou District
- City
- Ningbo City Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K232121
Owner / Operator
- Firm Name
- Ningbo Baichen Medical Devices Co., Ltd
- Operator Number
- 10088801
- Address
- Room 2101, No.666 Taikang Middle Road, Yinzhou District
- City
- Ningbo City
- State
- Zhejiang
- Postal Code
- 315000
- Country
- CN
- Correspondent
- Xiaolong Wu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wheelchair, Powered | ITI | Class 2 | Physical Medicine | No | 2023-10-12 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2025-08-22 |
| Vehicle, Motorized 3-Wheeled | INI | Class 2 | Physical Medicine | No | 2026-01-06 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2025-08-22 |
Proprietary Names
Power wheelchair
Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)
Walking Cane
Mobility Scooter (BC-MS310)
Crutches
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device