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A & E Medical Corporation

USA · Farmingdale
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia — 5 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
28510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 28 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
7registered devices
Class I 1Class II 6
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
1active device licences
Class II 1
10 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS B 1CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
21active ARTG entries
Class I 4Class III 8IIa 4IIb 4Class Is (sterile) 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 States0 registration records, 28 510(k), 0 PMA, 8,879 excluded
Brazil7 confirmed, 2,570 excluded
Saudi Arabia0 confirmed, 968 excluded
Canada1 confirmed, 1,237 excluded
Manufacturer names merged into this page: A & E MEDICAL CORPORATION · E- Medical. · A&E MEDICAL CORPORATION
Same-named companies — This database also contains companies with near-identical names: A & A Medical, Inc., A.Z.E. Medical, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Farmingdale

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

31988
51989
11996
41997
21998
22000
72001
32018
12020

Registration details (sample)

MarketIdentifierNameClass / date
USK193479Sternal Cable System2020-03-23
USK181607Thorecon Rigid Fixation System2018-10-12
USK180582Sternal Cable System2018-05-31
BR80825010001DISPOSITIVO PARA ASPIRAÇÃO PLEURAL EASYVACClass II
BR80825010002VALVULA DE DRENAGEM PLEURAL TIPO HEIMLICHClass II
BR80825010003FRASCOS DE DRENAGEM PLEURAL COM SISTEMA EASYCONECTClass II
CA77446FASTLOCKClass II

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