FDA.reportPublic FDA data

Polybell (Guangzhou) Limited

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30087110963008711096Polybell (Guangzhou) Limited1N2026-01-01No. 50 West Street, XiHu Village Renhe Town, Baiyun District Guangzhou Guangdong CN 510470

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1519451524992481K260346Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)HGX2026-06-12
1519451101845178K241004Wearable 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)HGX2024-09-11
1519451319712311K233136Hygeia Express Powered Breast PumpHGX2024-03-13
1519451208045576
1519451379219597
1519451567592467
1519451856063280
1519451154964209

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HGX32026-06-12

GUDID#