FDA.report

AEROGEN LTD.

Matched from indexed company URL: AEROGEN LTD.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30041272933004127293AEROGEN LTD.1N2026-01-01M&M QUALTECH, PARKMORE BUSINESS PARK GALWAY IE --

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
05391517936353Aerogen® Solo Nebulizer System - Pouched Solo II Assembly (Top Seal)+35391540400info@aerogen.com
05391517937442Aerogen® Solo Nebulizer System - Solo Convenience Kit (5 Pack)+35391540400info@aerogen.com
05391517937732Aerogen® USB Controller System - AG-UC1000-US+35391540400info@aerogen.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
842091015625889K251615Aerogen Pro-X1 Controller SystemSFP2025-09-02
842091293595364K232507Aerogen®Solo Nebulizer SystemCAF2024-05-10
842092063154463K143719Aeroneb USB Contoller SystemCAF2015-07-10
842091603702472K133360AERONEB SOLO; AERONEB SOLO ADAPTERCAF2014-10-17
842091426983255K081650AERONEB GO NEBULIZERCAF2008-10-23
842091682978327K070642AERONEB PROFESSIONAL NEBULIZER SYSTEMCAF2007-05-07
842091675647049K030271VENTLAB BACTERIAL FILTER, MODEL BF100CAH2003-07-07
842091783479213K021175AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000CAF2002-05-15

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
CAF62024-05-10
SFP12025-09-02
CAH12003-07-07

PMN

GUDID

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