Data / Medical devices / China / Polybell (Guangzhou) Limited
Polybell (Guangzhou) Limited: FDA-registered device maker in Guangzhou Guangdong, China, 3 510(k) clearances
Polybell (Guangzhou) Limited is registered with the FDA (registration 3008711096) in Guangzhou Guangdong, China. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 12, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008711096
- Address
- No. 50 West Street, XiHu Village Renhe Town, Baiyun District, Guangzhou Guangdong, China, 510470
- Owner or operator
- POLYBELL (GUANGZHOU) LIMITED (10042954)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- January 14, 2013
- Registered through
- 2026
- Brand names listed
- Electric Breast Pump/ BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1128, H1129, H620, H705, H706, Hygeia, Hygeia Echo, Manual breast pump/BPG082, BH626, Wearable Breast Pump/ABP-1306, ABP-1306 PRO, baby proof me
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Ring, Teething, Fluid-Filled | KKO | 2 | Manufacturer | accessdata.fda.gov |
| Ring, Teething, Non-Fluid Filled | MEF | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2026 | K260346 | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) | HGX | Substantially Equivalent | Polybell (Guangzhou) Limited | accessdata.fda.gov |
| September 11, 2024 | K241004 | Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) | HGX | Substantially Equivalent | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | accessdata.fda.gov |
| March 13, 2024 | K233136 | Hygeia Express Powered Breast Pump | HGX | Substantially Equivalent | Hygeia II Medical Group, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Breast, Powered
- All makers of Pump, Breast, Non-Powered
- All makers of Ring, Teething, Fluid-Filled
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- All makers of Ring, Teething, Non-Fluid Filled
Updated June 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.