FDA Device Entity Profile: Aerogen Ltd.

Known Identifiers & Locations

FEI Numbers 3003399703, 3004127293, 3018070843

Owner Operator Numbers 10024694

Locations Covered Co. Clare, IE; DANGAN Galway, IE; GALWAY, IE

Registered Establishments (3)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3003399703	AEROGEN LTD	DANGAN Galway, IE	Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility	View Details
3004127293	AEROGEN LTD.	GALWAY, IE	Repack or Relabel Medical Device,Manufacture Medical Device	View Details
3018070843	Aerogen Shannon	Co. Clare, IE	Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

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