Polybell (Guangzhou) Limited
Manufacturer and brand owner in Guangzhou, Guangdong, China. 5 device types, 1 product catalogued, 1 clearance.
Polybell (Guangzhou) Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Pump, Breast, Powered, Pump, Breast, Non-Powered and 3 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2013.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3008711096 |
| FEI number | 3008711096 |
| DUNS | 545905049 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | No. 50 West Street, XiHu Village |
| Postal code | 510470 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | baby proof me | 2016 | 58 |
| Pump, Breast, Non-Powered | Class 1 | Hygeia, Manual breast pump/BPG082, BH626 | 2019 | 33 |
| Pump, Breast, Powered | Class 2 | Hygeia Echo, Electric Breast Pump/ BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1128, H1129, H620, H705, H706, Wearable Breast Pump/ABP-1306, ABP-1306 PRO | 2024 | 40 |
| Ring, Teething, Fluid-Filled | Class 2 | 2019 | 18 | |
| Ring, Teething, Non-Fluid Filled | Class 1 | 2013 | 42 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Fatone | HGX | 13 |
Clearances
1 clearance names Polybell (Guangzhou) Limited as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260346 | 2026-06-12 | HGX | Traditional | This company |
| K241004 | 2024-09-11 | HGX | Traditional | Huizhou LVB Maternal AND Infant Supplies Co., Ltd. |
| K233136 | 2024-03-13 | HGX | Traditional | Hygeia II Medical Group, Inc. |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.