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Amerx Healthcare Corp

USA · Oldsmar
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Canada — 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
9listed device types
Class I 5Class II 1Class III 0unclassified 3
plus 10 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 States10 registration records, 3 510(k), 0 PMA
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: Amerx Healthcare Corp · AMERX HEALTH CARE CORPORATION · Amerx Health Care Corporation
Same-named companies — This database also contains companies with near-identical names: AMERX HEALTH CARE CORPORATION. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Oldsmar

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

21997 · K971918
12009 · K092086

FDA listed device types

showing 8 of 9
Dressing, Wound, Drug 1Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic 1Wound Dressing With Animal-Derived Material(S) 1Stocking, Medical Support (For General Medical Purposes) 1Dressing, Wound, Hydrophilic 1Tape And Bandage, Adhesive 1Gauze / Sponge,Nonresorbable For External Use 1Dressing, Wound, Occlusive 1

Registration details (sample)

MarketIdentifierNameClass / date
USK092086AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A20272009-07-30
USK971918AMERIGEL OINTMENT SATURATED WOUND DRESSING1997-08-12
USK970133AMERIGEL OINTMENT1997-04-14
SAME0000004713SFDAA00001Extremit-Ease—

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