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-AS7501-EUR, AG-AS7000-EUR, AG-AS7001-EUR.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
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 |