FDA Registration
Active
🇨🇳 China
Polybell (Guangzhou) Limited
Reg #: 3008711096
·
FEI: 3008711096
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Polybell (Guangzhou) Limited
- Registration Number
- 3008711096
- FEI Number
- 3008711096
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 50 West Street, XiHu Village, BangHu Town, BaiYun District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K233136
Owner / Operator
- Firm Name
- Polybell (Guangzhou) Limited
- Operator Number
- 10042954
- Address
- No. 50 West Street, XiHu Village, BangHu Town, BaiYun District
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 510470
- Country
- CN
US Agent
- Business Name
- QXNR
- Contact Name
- Robert Sokolowski
- Address
- 9698 Ash Ct
- City
- Blue Ash
- State
- OH
- ZIP
- 45242
- Country
- US
- [email protected]
- Phone
- 224 5755577
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2024-04-16 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)