Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004127293

FEI Number

3004127293

Entity Name

AEROGEN LTD.

City/State/Country

GALWAY, IE

Establishment Address

M&M QUALTECH, PARKMORE, BUSINESS PARK, GALWAY --, IE

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Aerogen Ltd. (Owner Number: 10024694)

Owner / Operator Contact Address

Galway Business Park, Dangan, Galway, IE-G H91 HE94, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133360

PMA Number

N/A

All Registered Proprietary Names

Aerogen® Solo Nebulizer System Aerogen Pro-X1 Controller System Aerogen Ltd Aerogen Solo Nebulizer System Aerogen Ultra

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2008-02-19
SFP	Ventilator-Compatible Nebulizer	Anesthesiology	Class 2	868.5630	2025-09-30
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2024-06-14
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2015-09-22

Official Correspondent

Thelma Marley

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Aerogen Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018070843	Aerogen Shannon	Co. Clare, IE
3003399703	AEROGEN LTD	DANGAN Galway, IE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

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3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004127293. Last updated year: 2026. Please use registration number 3004127293 when referencing this establishment in official correspondence.