HomeUSAAWARENESS TECHNOLOGY, INC.

AWARENESS TECHNOLOGY, INC.

USA · Palm City
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Russia — 4 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 4Class II 3Class III 0
plus 5 registration records and 18 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
12registered devices
Class I 2Class II 10
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
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
6active registrations
Class 2a 5Class 2b 1
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 States5 registration records, 18 510(k), 0 PMA
Brazil12 confirmed, 0 excluded
Canada1 confirmed, 1 excluded
Manufacturer names merged into this page: AWARENESS TECHNOLOGY, INC. · AWARENESS TECHNOLOGY INC. · AWARENESS TECHNOLOGY INC

Company information

Country
USA
City
Palm City

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

41985
21986
21987
11988
11989
11990
11992
21994
11998
12001
12002
12018

FDA listed device types

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Bath, Incubators/Water, All 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Electrode, Ion Specific, Potassium 1Electrode, Ion Specific, Sodium 1Electrode, Ion-Specific, Chloride 1

Registration details (sample)

MarketIdentifierNameClass / date
USK171476SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)2018-02-27
USK013420CHEMWELL, ALSO KNOWN AS PROJECT 29002002-07-19
USK010877CHEMWELL, MODEL 29002001-05-23
BR10269360266ANALISADOR AUTOMÁTICO DE IMUNOENSAIOClass II
BR80464810394CHEMWELL MOD 2902Class II
BR80464810395CHEMWELL TClass II
CA73433CHEM WELL 2900 SERIES BIOCHEMICAL ANALYZERClass II

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