Aerogen Ltd
IE-MF-000004597 · Ireland · Galway
Aerogen Ltd is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 26 |
|---|---|
| Class IIb | 7 |
Most frequent device types declared: AG-AS3010, AG-AS3100, AG-AS3180, AG-AS3300, AG-AS7000-EUR.
Devices declared under this manufacturer
- Aerogen Solo Adult T-Piece 22mm
- Aerogen Solo CNTS Syringe & Cap(20 Pack)
- Aerogen Solo Convenience Kit (10 Pack)
- Aerogen Solo Kit 15 mm
- Aerogen Solo Nebuliser (25 Pack)
- Aerogen Solo Nebuliser (5 Pack)
- Aerogen Solo Ped T-Piece 12mm
- Aerogen USB Controller
- Aerogen USB Controller AC/DC Adapter (EU)
- Aerogen Ultra Starter Kit with I-Guard™ Aerosol Mask (Adult)
- Aerogen Ultra Starter Kit with I-Guard™ Aerosol Mask (Ped)
- Aerogen Ultra with I-Guard™ Aerosol Mask (Adult)
Showing 12 of 33 declared devices.
Catalogue references include AG-AS3025, AG-AS3100, AG-AS3180, AG-AS3600, AG-AS7502-EUR, AG-UC1000-IN.
European nomenclature codes declared: R060101, R0699.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AEROGEN LTD (IE) · FDA 3003399703 |
| Devices in EUDAMED | 33 |
| Country of registration | Ireland |
Device-level evidence
| Devices with a numeric GTIN | 33 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 6.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | AEROGEN LTD |
What it holds in Canada
| Licences on record | 14 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 14 |
| First licensed | 2004-12-08 |
Licence types: Device Family (5), System (3), Device Group Family (3), Device Group (2).
Licensed under: AEROGEN PROFESSIONAL NEBULIZER SYSTEM, AEROGEN SOLO NEBULIZER KIT, AEROGEN PRO-X NEBULIZER, AEROGEN SOLO NEBULIZER KITS, DISPOSABLE T-PIECE, DISPOSABLE PEDIATRIC T-ADAPTER KIT.
North American profile: Both markets. Aerogen Ltd is registered in both the United States and Canada.