FDA Registration
Active
🇨🇳 China
Polybell (Guangzhou) Limited
Reg #: 3008711096
·
FEI: 3008711096
·
Expires 2026
Products
5
Proprietary Names
4
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Polybell (Guangzhou) Limited
- Registration Number
- 3008711096
- FEI Number
- 3008711096
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 50 West Street, XiHu Village, Renhe Town, Baiyun District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K260346
Owner / Operator
- Firm Name
- POLYBELL (GUANGZHOU) LIMITED
- Operator Number
- 10042954
- Address
- No. 50 West Street, XiHu Village, Renhe 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 | 2026-06-14 |
| Ring, Teething, Fluid-Filled | KKO | Class 2 | Dental | No | 2019-12-20 |
| Ring, Teething, Non-Fluid Filled | MEF | Class 1 | Dental | No | 2013-01-14 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2016-09-12 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2019-12-20 |
Proprietary Names
Electric Breast Pump/ BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1128, H1129, H620, H705, H706
baby proof me
Manual breast pump/BPG082, BH626
Hygeia
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)