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Aerogen Limited

Ireland · Dangan

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

3listed device types

Class I 0Class II 3Class III 0

plus 13 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

18 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

13active ARTG entries

Class I 4IIa 9

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

4registrations

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 States13 registration records, 10 510(k), 0 PMA, 3 excluded

Brazil2 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: AEROGEN LTD. · AEROGEN LTD · AEROGEN LTD.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251615	Aerogen Pro-X1 Controller System	2025-09-02
US	K232507	Aerogen®Solo Nebulizer System	2024-05-10
US	K143719	Aeroneb USB Contoller System	2015-07-10
BR	81464759020	Sistema Aerogen Solo	Class II
BR	81464759063	Sistema do Controlador Aerogen USB	Class II
CA	66926	AERONEB GO NEBULISER SYSTEM	Class II
CA	79263	DISPOSABLE LUER CONNECTORS	Class II
CA	86347	NIVO NEBULIZER SYSTEM	Class II

Aerogen Limited

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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