HomeUSAAirsep Corporation

Airsep Corporation

USA · Buffalo
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Singapore, Israel, Russia — 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
1listed device types
Class I 0Class II 1Class III 0
plus 2 registration records and 19 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
2active device licences
Class II 2
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
6device registrations
CLASS B 6
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 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 States2 registration records, 19 510(k), 0 PMA
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: AIRSEP CORP. · AIRSEP CORP

Company information

Country
USA
City
Buffalo

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

11987
11989
21995
31996
11997
11998
11999
42000
22002
12008
12011
12015

FDA listed device types

Generator, Oxygen, Portable 1

Registration details (sample)

MarketIdentifierNameClass / date
USK150930Deployable Oxygen Generation System-Smaill (DOGS-S)2015-12-18
USK101154CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L2011-03-28
USK080348OXISCAN II DATA MANAGEMENT SYSTEM2008-10-09
CA15521MYSTIQUEClass II
CA62227IMPULSE OXYGEN CONSERVER DEVICEClass II

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