HomeUSAHYDROFERA, LLC.

HYDROFERA, LLC.

USA · Manchester
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, 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
7listed device types
Class I 5Class II 0Class III 0unclassified 2
plus 18 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
3 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
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 States18 registration records, 7 510(k), 0 PMA
Manufacturer names merged into this page: HYDROFERA, LLC. · HYDROFERA, LLC

Company information

Country
USA
City
Manchester

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

21998 · K974313
11999 · K983276
12002 · K013462
12003 · K023138
12014 · K130670
12019 · K190268

FDA listed device types

Dressing, Wound, Drug 1Gauze/Sponge, Internal 1Gauze/Sponge, Internal, X-Ray Detectable 1Ear Wick 1Instrument, Manual, Surgical, General Use 1Balloon, Epistaxis 1Gauze / Sponge,Nonresorbable For External Use 1

Registration details (sample)

MarketIdentifierNameClass / date
USK190268Hydrofera Blue READY - Border2019-11-06
USK130670HYDROFERA BLUE PU BACTERIOSTATIC DRESSING2014-01-02
USK023138HYDROFERA BACTERIOSTATIC WOUND DRESSING2003-01-17

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