HomeUSAAIR TECHNIQUES, INC.

AIR TECHNIQUES, INC.

USA · Melville
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel, Russia — 9 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
6listed device types
Class I 4Class II 2Class III 0
plus 7 registration records and 18 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class I 2Class II 3
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
3registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
8active device licences
Class II 8
27 including historic records
TWTaiwanTFDA
5valid device licences
Class I 1Class II 4
SGSingaporeHSA SMDR
3device registrations
CLASS B 3
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
9active ARTG entries
Class I 5IIa 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
7registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 States7 registration records, 18 510(k), 0 PMA, 5 excluded
Brazil5 confirmed, 2 excluded
Saudi Arabia3 confirmed, 0 excluded
Canada8 confirmed, 1 excluded
Manufacturer names merged into this page: AIR TECHNIQUES, INC. · AIR TECHNIQUES INC. · AIR TECHNIQUES, INC · AIR TECHNIQUES, INC.&#8194.&#8194.&#8194. · Air Techniques Inc. · Air Techniques, Inc.

Company information

Country
USA
City
Melville

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

21995
31998
11999
12000
12002
22003
22004
12005
12006
12009
12010
22019

FDA listed device types

Tubing, Pressure And Accessories 1Unit, Operative Dental, Accessories 1Tube Mount, X-Ray, Diagnostic 1Film, Radiographic 1Dental Barriers And Sleeves 1System, X-Ray, Extraoral Source, Digital 1

Registration details (sample)

MarketIdentifierNameClass / date
USK191623ScanX Touch/ScanX Duo Touch2019-08-21
USK190949ScanX Barrier Envelopes2019-07-26
USK101289SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB2010-08-03
BR81504799003Software para processamento de imagens médicas - DBSWINClass II
BR81504799002ScanX Sistema Digital de Diágnóstico por ImagemClass II
BR81504790119PLACA DE FÓSFORO PSPClass II
SAME0000004657SFDAA00001AirStar Clinical Air Compressor
SAME0000004657SFDAA00002AirStar Eco
CA559AIRDENT IIClass II
CA62237PROVECTA 70Class II
CA62284CONTROL KITClass II

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