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Hygeia Medical, Inc.

USA · Carlsbad
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Australia — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
2listed device types
Class I 1Class II 1Class III 0
plus 8 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
Class I 6
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States8 registration records, 5 510(k), 0 PMA, 3 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: HYGEIA II MEDICAL GROUP, INC. · BEIJING HYGEIA MEDICAL INSTRUMENTS CO., LTD.
Same-named companies — This database also contains companies with near-identical names: HYGEIA II MEDICAL GROUP, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Carlsbad

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12009 · K081932
12019 · K190465
12020 · K200406
12022 · K212955
12024 · K233136

FDA listed device types

Pump, Breast, Powered 1Pump, Breast, Non-Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233136Hygeia Express Powered Breast Pump2024-03-13
USK212955Fit Pro Breast Pump2022-03-15
USK200406Evolve Breast Pump2020-03-18
BR10351890014Alginato para Impressão de MoldagemClass I

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