Is this your brand? Sign in to claim ownership.

Aerogen Ltd

Ireland·IE-MF-000004597

Last updated September 17, 2026

Information

Country: Ireland
Address: Galway Business Park, Galway, Ireland
Website: www.aerogen.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +353 91 540 400
PRRC Contact: Diane Hassett
EUDAMED SRN: IE-MF-000004597
FDA FEI Number: 3003399703
DUNS Number: —

Catalogue (35)

Device	Model / Reference	Registries	Class	Status
Aerogen Ultra-10 PK	AG-AS7000-EUR	EUDAMED	Class IIa	Active
Aerogen Ultra with I-Guard™ Aerosol Mask (Ped)	AG-AS7002-EUR	EUDAMED	Class IIb	Active
Aerogen Ultra (10 Pack)	AG-AS7000-EU	EUDAMED	Class IIa	Active
Aerogen Solo T-Piece 22mm	AG-AS3010	EUDAMED	Class IIb	Active
Aerogen Solo Nebuliser (10 Pack)	AG-AS3200	EUDAMEDFDA UDI	Class IIa	Active
Continuous Nebulization Tube Set (cnts) Tubing: Ag-As3075 + Syringe: Ag-As3085; Continous Nebulization Tube Set (cnts) S	K103635	FDA 510(k)	Class II	Active
Aerogen®Solo Nebulizer System	K232507	FDA 510(k)	Class II	Active
Aeroneb Solo; Aeroneb Solo Adapter	K133360	FDA 510(k)	Class II	Active
Aeroneb Pro	K120939	FDA 510(k)	Class II	Active
Aerogen Pro-X1 Controller System	K251615	FDA 510(k)	Class II	Active
Aerogen Solo T-Piece 10 mm	AG-AS3036	EUDAMED	Class IIb	Active
Aerogen USB Controller	AG-UC1000-IN	EUDAMED	Class IIa	Active
Aerogen Ultra Starter Kit Ped Mask	AG-AS7502-EUR	EUDAMED	Class IIb	Active
Aerogen Solo T-Piece 15mm	AG-AS3020	EUDAMED	Class IIb	Active
Aerogen Solo Nebuliser (10 Pack)	AG-AS3200	EUDAMED	Class IIb	Active
Aerogen Ultra Oxygen Tubing 10-Pack	AG-AS7008-EUR	EUDAMED	Class IIb	Active
Aerogen Solo T-Piece 12mm	AG-AS3035	EUDAMED	Class IIb	Active
Aerogen USB Controller	AG-UC1000-NE	EUDAMED	Class IIa	Active
Aerogen Solo Nebuliser (5 Pack)	AG-AS3100	EUDAMED	Class IIb	Active
Aerogen Ultra with I-Guard™ Aerosol Mask (Adult)	AG-AS7001-EUR	EUDAMED	Class IIb	Active
Aerogen Solo Convenience Kit (5 Pack)	AG-AS3300	EUDAMED	Class IIb	Active
Aerogen USB Controller AC/DC Adapter (EU)	AG-UC1040-EU	EUDAMED	Class IIb	Active
Aerogen USB Controller AC/DC Adapter (UK)	AG-UC1040-UK	EUDAMED	Class IIb	Active
Aerogen CNTS Tube Set (10 pack)	AG-AS3170	EUDAMED	Class IIb	Active
Aerogen USB Controller	AG-UC1000-CE	EUDAMED	Class IIb	Active
Aerogen Ultra Mouthpiece 10 Pack	AG-AS7003-EUR	EUDAMED	Class IIb	Active
Aerogen CNTS Syringe & Cap 20 Pack	AG-AS3180	EUDAMED	Class IIb	Active
Aerogen USB Controller	AG-UC1000-EE	EUDAMED	Class IIb	Active
Aerogen Solo Kit 15mm	AG-AS3025	EUDAMED	Class IIb	Active
Aerogen Ultra Starter Kit Adult Mask	AG-AS7501-EUR	EUDAMED	Class IIb	Active
Aerogen Solo T-Piece Plug	AG-AS3450	EUDAMED	Class IIb	Active
Aerogen Solo Adult T-Piece 22mm	AG-AS3010	EUDAMEDFDA UDI	Class IIa	Active
Aerogen USB Controller	AG-UC1000-UK	EUDAMED	Class IIb	Active
Aerogen Solo Nebuliser (25 Pack)	AG-AS3600	EUDAMED	Class IIb	Active
Aerogen Solo Convenience Kit (10 Pack)	AG-AS3350	EUDAMED	Class IIb	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Aerogen, Inc. US