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Airgas Therapeutics, LLC

USA · Plumsteadville

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, 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

15listed device types

Class I 4Class II 6Class III 5

plus 15 registration records and 2 510(k), 20 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 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

0active device licences

4 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States15 registration records, 2 510(k), 20 PMA, 10 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: Airgas Therapeutics LLC · AIRGAS THERAPEUTICS, LLC

FDA 510(k) clearances by year

12023 · K212409

12025 · K242374

FDA listed device types

showing 8 of 15

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs 1Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation 1Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation 1Gases Used Within Eye To Place Pressure On Detached Retina 1Organ Care System (Ocs) Heart System 1System, Balloon, Intra-Aortic And Control 1Analyzer, Nitric Oxide 1Analyzer, Gas, Oxygen, Gaseous-Phase 1

Market	Identifier	Name	Class / date
US	K242374	ULSPIRA TS Nitric Oxide Therapy System	2025-01-17
US	K212409	Ulspira TS Nitric Oxide Therapy System	2023-06-30
BR	81869420157	ISPAN Regulador	Class I

Airgas Therapeutics, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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