HomeUSAAirlife, Inc.

Airlife, Inc.

USA · Grand Rapids
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Israel — 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
76510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 76 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
32registered devices
Class I 9Class II 23
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
3active device licences
Class II 3
77 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
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, 76 510(k), 0 PMA, 2 excluded
Brazil32 confirmed, 0 excluded
Canada3 confirmed, 2 excluded
Manufacturer names merged into this page: AIRLIFE

Company information

Country
USA
City
Grand Rapids

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

451979
101980
101981
21982
71983 · K834077
21984 · K834570

Registration details (sample)

MarketIdentifierNameClass / date
USK834570VOLUME VENTILATOR CIRCUIT W/WATER TRAP1984-03-05
USK834573AQUA TRAP1984-03-05
USK834077SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN1983-12-12
BR80102511585Estilete para Tubo Endotraqueal Vital SignsClass I
BR80102511586Infusor de Pressão Vital SingsClass I
BR80102511599Balão Respiratório Vital SignsClass II
CA8072AIRLIFE VENTILATOR ELBOW WITH SUCTION PORTClass II
CA8086AIRLIFE ISOTHERMAL BREATHING CIRCUIT ACCESSORIES - EXHALATION VALVE ASSEMBLY KITClass II
CA8238OXYGEN CATHETERClass II

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