Aerogen Ltd
World leader in vibrating mesh nebuliser technology for critical care.
Aerogen designs and manufactures vibrating mesh nebuliser systems for aerosol drug delivery in intensive care and acute respiratory settings. Based in Galway, the company's technology has been used to treat over 30 million patients across 80 countries and is integrated into ventilator circuits for ICU, neonatal and emergency care. Named Ireland's largest indigenous medtech company, Aerogen was recognised as Irish Exporter of the Year by the Irish Exporters Association.
- Type
- Manufacturer
- Location
- Galway, Ireland
- Founded
- 1997
- Website
- aerogen.com
- Categories
- Medical & Healthcare Supplies
- Markets
- United States, Germany, United Kingdom, France, Japan
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-03 Mail server of the company domain
- debarment-clear (green), checked 2026-08-03 OpenSanctions
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- sanctions-clear (green), checked 2026-08-03 OpenSanctions
- fda-registered (green), checked 2026-08-03 FDA
- domain-registered (green), checked 2026-08-03 Domain registry record
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
Claimed certifications
- CE Marking EU NANDO (notified bodies)
- FDA Registered FDA Establishment Registration
- ISO 9001, Quality Management IAF CertSearch
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)