Contact:haixiao@sungolytest.com+86 158 2169 5110 (WeChat)+86 132 4819 8029 Members 中文
Home›USA›A.Z.E. Medical, Inc.

A.Z.E. Medical, Inc.

USA · Palm Harobor
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, 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
5510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 1Class II 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
1active device licences
Class II 1
10 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 States0 registration records, 5 510(k), 0 PMA, 8,880 excluded
Brazil2 confirmed, 2,571 excluded
Saudi Arabia0 confirmed, 968 excluded
Canada1 confirmed, 1,237 excluded
Manufacturer names merged into this page: A & E MEDICAL CORPORATION · A&E MEDICAL CORPORATION
Same-named companies — This database also contains companies with near-identical names: A & A Medical, Inc., A & E Medical Corporation. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Palm Harobor

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

11996 · K952967
32018 · K181607
12020 · K193479

Registration details (sample)

MarketIdentifierNameClass / date
USK193479Sternal Cable System2020-03-23
USK181607Thorecon Rigid Fixation System2018-10-12
USK180582Sternal Cable System2018-05-31
BR80094179008Perfurador Cirúrgico de RotaçãoClass II
BR80094170109Cabo Descartável Para Paciente 2.0 MYO/WIRE®Class I
CA77446FASTLOCKClass II

Similar companies

Abaxis
USA · markets 9
Accorto Regulatory Solutions LLC
USA · markets 0
Accumold LLC
USA · markets 1
AccuVein Inc.
USA · markets 8
Acme Monaco Corporation
USA · markets 4
ACON Laboratories, Inc.
USA · markets 9
Is this your company? Claim the page, add information or report a data error.Claim / report an error →