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AIRON CORPORATION

USA · Melbourne

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, 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

4listed device types

Class I 0Class II 4Class III 0

plus 5 registration records and 4 510(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

3active device licences

Class II 3

6 including historic records

TWTaiwanTFDA

3valid device licences

Class I 1Class II 2

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States5 registration records, 4 510(k), 0 PMA

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: AIRON CORPORATION

FDA 510(k) clearances by year

12003 · K024344

12004 · K043085

12008 · K080692

12012 · K121379

FDA listed device types

Filter, Bacterial, Breathing-Circuit 1Ventilator, Emergency, Powered (Resuscitator) 1Ventilator, Continuous, Facility Use 1Attachment, Breathing, Positive End Expiratory Pressure 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K121379	PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY	2012-10-11
US	K080692	MACS CPAP SYSTEM	2008-06-20
US	K043085	MODIFICATION TO: PNEUTON VENTILATOR	2004-12-20
CA	92775	NASAL PRONG	Class II
CA	92828	NASAL MASK	Class II
CA	92960	MINIFLOW PATIENT INTERFACE	Class II

AIRON CORPORATION

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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