FDA Registration
Active
🇨🇳 China
BR828-5
Reg #: 3027332487
·
FEI: 3027332487
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- BRADACARE (XIAMEN) HEALTH TECHNOLOGY CO.,LTD
- Registration Number
- 3027332487
- FEI Number
- 3027332487
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.1368, Jicheng Road, Tong'an Area
- City
- Xiamen City Fujian
- Country
- CN
Owner / Operator
- Firm Name
- Bradacare (XiaMen) Health Technology Co.,LTD
- Operator Number
- 10087685
- Address
- No.1368, Jicheng Road, Tong'an Area
- City
- Xiamen City
- State
- Fujian
- Postal Code
- 361100
- Country
- CN
- Correspondent
- Hao Liu
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 |
|---|---|---|---|---|---|
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2023-03-27 |
Proprietary Names
BR828-5
BR0003/BR0003-1/BR0003-2/BR0003-3, BR0005/BR0005-1/BR0005-2/BR0005-3, BR0006/BR0006-1/BR0006-2/BR0006-3
BR0006S, BR0006S-1, BR0006S-2, BR0006S-3, BR0006-5, BR0006S-5, BR808, BR808-1, BR808-2, BR808-3, BR808-5, BR808S,
Rollator Walker, BR0001/BR0001-1/BR0001-2/BR0001-3, BR0002/BR0002-1/BR0002-2/BR0002-3,
BR808S-1, BR808S-2, BR808S-3, BR808S-5, BR818, BR818-1, BR818-2, BR818-3, BR818-5, BR828, BR828-1, BR828-2, BR828-3,
BR808, BR808-1, BR808-2, BR808-3, BR808-5, BR808-6, BR0005PLUS, BR0005PLUS-1, BR0005PLUS-2, BR0005PLUS-3, BR0005PLUS-5,
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device