Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003399703

FEI Number

3003399703

Entity Name

AEROGEN LTD

City/State/Country

DANGAN Galway, IE

Establishment Address

GALWAY BUSINESS PARK, DANGAN Galway --, IE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

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

K070642

PMA Number

N/A

All Registered Proprietary Names

Aerogen USB Controller System Aerogen Ultra Aerogen Solo Nebulizer System Aeroneb Professional Nebulisation System Continuous Nebulization Tube Set (CNTS) Aerogen Pro-X1 Controller System Aerogen Ltd Aerogen® Solo Nebulizer System

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	2015-09-22
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2015-09-22
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2024-06-14
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2011-05-17
SFP	Ventilator-Compatible Nebulizer	Anesthesiology	Class 2	868.5630	2025-09-30
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2008-02-19

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
3004127293	AEROGEN LTD.	GALWAY, IE
3018070843	Aerogen Shannon	Co. Clare, 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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3005998497	SUNMED AP, LTD.	ZHUHAI Guangdong, CN
3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003399703. Last updated year: 2026. Please use registration number 3003399703 when referencing this establishment in official correspondence.