Aerogen L T D

FDA Filings

This page includes the latest FDA filings for Aerogen L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004127293
• FEI Number: 3004127293
• Name: AEROGEN LTD.
• Owner & Operator: Aerogen Ltd.
• Contact Address: Galway Business Park Dangan; Galway IE-G Galway H91 HE94 IE
• Official Correspondent:
  • James Langan
  • 353-91-540411-x
• US Agent:
  • Rene van de Zande
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: M&M QUALTECH, PARKMORE BUSINESS PARK; GALWAY Galway, -- IE
• Establishment Type: Manufacture Medical Device

• Registration Number: 3003399703
• FEI Number: 3003399703
• Name: AEROGEN LTD
• Owner & Operator: Aerogen Ltd.
• Contact Address: Galway Business Park Dangan; Galway IE-G Galway H91 HE94 IE
• Official Correspondent:
  • James Langan
  • 353-91-540411-x
• US Agent:
  • Rene van de Zande
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • usagent@emergogroup.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: GALWAY BUSINESS PARK ; DANGAN Galway, -- IE
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 05391517936896 AEROGEN LIMITED	Aerogen® Solo; Aerogen Ultra	2023-10-11
GUDID 05391517936797 AEROGEN LIMITED	Aerogen® Solo; Aerogen Ultra	2023-10-11
GUDID 05391517936780 AEROGEN LIMITED	Aerogen® Solo; Aerogen Ultra	2023-10-11
GUDID 05391517936339 AEROGEN LIMITED	Aerogen® Solo; Aerogen Ultra	2022-06-10
GUDID 05391517936322 AEROGEN LIMITED	Aerogen® Solo; Aerogen Ultra	2022-06-10
GUDID 05391517936315 AEROGEN LIMITED	Aerogen® Solo; Aerogen Ultra	2022-06-10
GUDID 05391517936308 AEROGEN LIMITED	Aerogen® Solo; Aerogen Ultra	2022-06-10
GUDID 05391517935585 AEROGEN LIMITED	Aerogen Solo Nebulizer System	2022-06-10
GUDID 05391517935578 AEROGEN LIMITED	Aerogen Solo Nebulizer System	2022-06-10
GUDID 05391517935561 AEROGEN LIMITED	Aerogen Solo Nebulizer System	2022-06-10
GUDID 05391517934304 AEROGEN LIMITED	Aerogen Solo Nebulizer System	2022-06-10
GUDID 05391517936292 AEROGEN LIMITED	Aerogen® Solo; Aerogen Ultra	2021-09-20
GUDID 05391517936223 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2021-09-20
GUDID 05391517936216 AEROGEN LIMITED	Aerogen® Solo Continuous Nebulization Tube Set	2021-03-31
GUDID 05391517936209 AEROGEN LIMITED	Aerogen® Solo Continuous Nebulization Tube Set	2021-03-31
GUDID 05391517936193 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2021-03-05
GUDID 05391517935776 AEROGEN LIMITED	Aerogen® Solo; Aerogen Ultra	2020-08-03
GUDID 05391517935769 AEROGEN LIMITED	Aerogen® Solo; Aerogen Ultra	2020-08-03
GUDID 05391517934311 AEROGEN LIMITED	Aerogen Solo Nebulizer System	2020-07-08
GUDID 05391517935011 AEROGEN LIMITED	Aerogen Solo Nebulizer System	2020-06-17
GUDID 05391517935035 AEROGEN LIMITED	Aerogen® USB Controller System	2020-03-17
GUDID 05391517934021 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2019-06-13
GUDID 05391517933321 AEROGEN LIMITED	Aerogen® Solo; Aerogen Ultra	2018-10-25
GUDID 05391517933710 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-09-24
GUDID 05391517931938 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-09-24
GUDID 05391517931488 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-09-24
GUDID 05391517931341 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-09-24
GUDID 05391517931310 AEROGEN LIMITED	Aerogen® USB Controller System	2018-09-24
GUDID 05391517931297 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-09-24
GUDID 05391517930740 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-09-24
GUDID 05391517930177 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-09-24
GUDID 05391517930160 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-09-24
GUDID 05391517930108 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-09-24
GUDID 05391517930085 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-09-24
GUDID 05391517930061 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-09-24
GUDID 05391517930047 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-09-24
GUDID 05391517930030 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-09-24
GUDID 05391517930016 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-09-24
GUDID 05391517933475 AEROGEN LIMITED	NIVO Nebulizer System	2018-07-06
GUDID 05391517933468 AEROGEN LIMITED	NIVO Nebulizer System	2018-07-06
GUDID 05391517933451 AEROGEN LIMITED	NIVO Nebulizer System	2018-07-06
GUDID 05391517933444 AEROGEN LIMITED	NIVO Nebulizer System	2018-07-06
GUDID 05391517933437 AEROGEN LIMITED	NIVO Nebulizer System	2018-07-06
GUDID 05391517933420 AEROGEN LIMITED	NIVO Nebulizer System	2018-07-06
GUDID 05391517933376 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-07-06
GUDID 05391517933369 AEROGEN LIMITED	Aerogen® USB Controller System	2018-07-06
GUDID 05391517933352 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517933338 AEROGEN LIMITED	Aerogen® Solo; Aerogen Ultra	2018-07-06
GUDID 05391517933314 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517933284 AEROGEN LIMITED	Aerogen® Solo Continuous Nebulization Tube Set	2018-07-06
GUDID 05391517933260 AEROGEN LIMITED	Aerogen® Solo Continuous Nebulization Tube Set	2018-07-06
GUDID 05391517933253 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517933246 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517933239 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517933222 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517933215 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517933208 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517933192 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517933154 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-07-06
GUDID 05391517933147 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-07-06
GUDID 05391517933130 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-07-06
GUDID 05391517933116 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-07-06
GUDID 05391517933109 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-07-06
GUDID 05391517933093 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-07-06
GUDID 05391517933079 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-07-06
GUDID 05391517933062 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-07-06
GUDID 05391517933055 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-07-06
GUDID 05391517933024 AEROGEN LIMITED	Aerogen® Professional Nebulizer System	2018-07-06
GUDID 05391517933000 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517932997 AEROGEN LIMITED	Aerogen® USB Controller System	2018-07-06
GUDID 05391517932973 AEROGEN LIMITED	Aerogen® USB Controller System	2018-07-06
GUDID 05391517932966 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517932522 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517932515 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517932508 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517932355 AEROGEN LIMITED	Aerogen® Solo; Aerogen Ultra	2018-07-06
GUDID 05391517931945 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517931914 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517931907 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517931648 AEROGEN LIMITED	Aerogen® Solo Nebulization System	2018-07-06
GUDID 05391517931181 AEROGEN LIMITED	Aerogen® Solo Continuous Nebulization Tube Set	2018-07-06
GUDID 05391517930702 AEROGEN LIMITED	Aerogen® Solo; Aerogen Ultra	2018-07-06
GUDID 05391517930627 AEROGEN LIMITED	Aerogen® Solo Nebulization System	2018-07-06
GUDID 05391517930610 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517930603 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517930580 AEROGEN LIMITED	Aerogen® Solo; Aerogen Ultra	2018-07-06
GUDID 05391517930566 AEROGEN LIMITED	Aerogen® USB Controller System	2018-07-06
GUDID 05391517930542 AEROGEN LIMITED	Aerogen® USB Controller System	2018-07-06
GUDID 05391517930412 AEROGEN LIMITED	Aerogen® Solo Continuous Nebulization Tube Set	2018-07-06
GUDID 05391517930405 AEROGEN LIMITED	Aerogen® Solo Continuous Nebulization Tube Set	2018-07-06
GUDID 05391517930399 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517930306 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517930290 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517930283 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517930276 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517930269 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517930252 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517930245 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517930238 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
GUDID 05391517930221 AEROGEN LIMITED	Aerogen® Solo Nebulizer System	2018-07-06
PMN K143719 | CAF AEROGEN LTD.	Aerogen USB Controller System	2015-09-22
PMN K143719 | CAF AEROGEN LTD [Aerogen Ltd.]	Aerogen USB Controller System	2015-09-22
PMN K133360 | CAF AEROGEN LTD.	Aerogen Ultra	2015-09-22
PMN K133360 | CAF AEROGEN LTD [Aerogen Ltd.]	Aerogen Ultra	2015-09-22
PMN K143719 Aerogen Limited	Aeroneb USB Contoller System	2015-07-10
PMN K133360 AEROGEN LTD	AERONEB SOLO; AERONEB SOLO ADAPTER	2014-10-17
PMN K120939 AEROGEN LTD	AERONEB PRO	2012-04-26
PMN K103635 | CAF AEROGEN LTD [Aerogen Ltd.]	Aeroneb Professional Nebulisation System	2011-05-17
PMN K103635 AEROGEN LTD	CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S	2011-05-13
PMN K102240 | CAF AEROGEN LTD [Aerogen Ltd.]	NIVO Nebulizer System	2011-04-04
PMN K081650 | CAF AEROGEN LTD.	Aeroneb Go Nebulizer	2008-12-12
PMN K081650 | CAF AEROGEN LTD [Aerogen Ltd.]	Aeroneb Go Nebulizer	2008-12-12
PMN K070642 | CAF AEROGEN LTD.	Aeroneb Professional System	2008-02-19
PMN K070642 | CAF AEROGEN LTD [Aerogen Ltd.]	Aeroneb Professional System	2008-02-19
PMN K021175 | CAF AEROGEN LTD.	Aeroneb Professional System	2008-02-19
PMN K021175 | CAF AEROGEN LTD [Aerogen Ltd.]	Aeroneb Professional System	2008-02-19

Similar & Related FDA Registered Companies

• AEROGEN IRELAND, LTD.

Related Finance Registrations

NCAGE Code	SGLR6	AEROGEN LTD
CAGE Code	SGLR6	AEROGEN LIMITED AEROGEN LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092512254	Rotterdam,Netherlands -> Charleston, South Carolina	MEDICAL SUPPLIES 90192000	96 CTN
2020092415983	Rotterdam,Netherlands -> Charleston, South Carolina	MEDICAL SUPPLIES 90192000	96 CTN
2020092317100	Rotterdam,Netherlands -> Charleston, South Carolina	MEDICAL SUPPLIES 90192000	96 CTN
2020092126746	Rotterdam,Netherlands -> Charleston, South Carolina	MEDICAL SUPPLIES 90192000	96 CTN
2020091931492	Rotterdam,Netherlands -> Houston, Texas	MEDICAL SUPPLIES HS: 9019200	226 CTN
2020091931492	Rotterdam,Netherlands -> Houston, Texas	MEDICAL SUPPLIES HS: 9019200	226 CTN
2020091256341	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	MEDICAL SUPPLIES 90192000	208 BOX