FDA.reportPublic FDA data

HYGEIA II MEDICAL GROUP, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30067744483006774448HYGEIA II MEDICAL GROUP, INC.1Y2026-01-016241 Yarrow Dr Ste A Carlsbad CA US 92011

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
855551530371284K241004Wearable 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
855551943915583K233136Hygeia Express Powered Breast PumpHGX2024-03-13
855551704130263K212955Fit Pro Breast PumpHGX2022-03-15
855551835726007K200406Evolve Breast PumpHGX2020-03-18
855551859455792K190465Evolve Breast PumpHGX2019-10-18
855551080157652K162870CIMLRE F1 and CIMILRE S3HGX2017-03-07
855551846806134K081932ENDEARE BREAST PUMPHGX2009-01-22
855551322160956

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HGX72024-09-11

PMN#