Statistics for Aerogen Ltd

40Total Devices

16Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

8Countries

Certificate health for Aerogen Ltd

No certificates registered for this manufacturer.

Devices by risk class

Device catalog for Aerogen Ltd

Showing 1–25 of 40 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Aerogen Solo Kit 15 mm	`AG-AS3025`	`05391517937763`	1	On the market
Aerogen CNTS Tube Set (10 pack)	`AG-AS3170`	`05391517938272`	1	On the market
Aerogen Solo Adult T-Piece 22mm	`AG-AS3010`	`05391517930252`	1	On the market
Aerogen Solo CNTS Syringe & Cap(20 Pack)	`AG-AS3180`	`05391517938265`	1	On the market
Aerogen Solo CNTS Syringe & Cap(20 Pack)	`AG-AS3180`	`05391517938265`	1	On the market
Aerogen Solo Convenience Kit (10 Pack)	`AG-AS3350`	`05391517937848`	1	On the market
Aerogen Solo Convenience Kit (5 Pack)	`AG-AS3300`	`05391517937831`	1	On the market
Aerogen Solo Nebuliser (10 Pack)	`AG-AS3200`	`05391517937824`	1	On the market
Aerogen Solo Nebuliser (10 Pack)	`AG-AS3200`	`05391517937824`	10	On the market
Aerogen Solo Nebuliser (10 Pack)	`AG-AS3200`	`05391517930245`	1	On the market
Aerogen Solo Nebuliser (25 Pack)	`AG-AS3600`	`05391517937862`	1	On the market
Aerogen Solo Nebuliser (25 Pack)	`AG-AS3600`	`05391517937862`	25	On the market
Aerogen Solo Nebuliser (5 Pack)	`AG-AS3100`	`05391517937794`	1	On the market
Aerogen Solo Nebuliser (5 Pack)	`AG-AS3100`	`05391517937794`	5	On the market
Aerogen Solo Ped T-Piece 10mm	`AG-AS3036`	`05391517937787`	1	On the market
Aerogen Solo Ped T-Piece 12mm	`AG-AS3035`	`05391517937770`	1	On the market
Aerogen Solo T-Piece 15mm	`AG-AS3020`	`05391517937756`	1	On the market
Aerogen Solo T-Piece 22mm	`AG-AS3010`	`05391517937749`	1	On the market
AG-AS3450	`AG-AS3450`	`05391517937855`	1	On the market
Aerogen Ultra (10 Pack)	`AG-AS7000-EU`	`05391517930573`	1	On the market
Aerogen Ultra Oxygen Tubing 10-Pack	`AG-AS7008-EUR`	`05391517938241`	1	On the market
Aerogen Ultra Starter Kit Adult Mask	`AG-AS7501-EUR`	`05391517937909`	1	On the market
Aerogen Ultra Starter Kit Adult Mask	`AG-AS7501-EUR`	`05391517937909`	1	On the market
Aerogen Ultra Starter Kit Ped Mask	`AG-AS7502-EUR`	`05391517937916`	1	On the market
Aerogen Ultra Starter Kit Ped Mask	`AG-AS7502-EUR`	`05391517937916`	1	On the market

1 2

Market presence of Aerogen Ltd

Devices placed in 8 countries

Austria28
Ireland5
Cyprus2
Germany1
Denmark1
Estonia1
Croatia1
Poland1

EUDAMED update: Jul 5, 2024

Aerogen Ltd

IE-MF-000004597

Active

Address: Galway Business Park, H91 HE94 Galway
Role: Manufacturer
Date of registration: May 19, 2021
Country: IE Ireland

About Aerogen Ltd

SRN: IE-MF-000004597
Role: Manufacturer
Country: Ireland
Organization name: Aerogen Ltd
EU VAT number: IE8277354F
EORI: IE8277354F
Trade register: 277354
Date of registration: May 19, 2021

Contact details for Aerogen Ltd

Address: GALWAY BUSINESS PARK DANGAN H91 HE94 GALWAY IRELAND
Phone: +353 91 540 400
Email: info@aerogen.com
Website: www.aerogen.com

Validator

Name: Health Products Regulatory Authority, Medical Devices Department
SRN: IE-CA-001
Phone: +353 1 676 4971
Email: devices@hpra.ie

Officers and regulatory representatives of Aerogen Ltd

MARLEY Thelma
The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
Hidden
HASSETT Diane
The conformity of the devices is appropriately checked, in accordance with the quality management system under, which the devices are manufactured, before a device is released.
Hidden
O'DWYER John
The post-market surveillance obligations are complied with in accordance Article 10(10) of The Regulation; and The reporting obligations referred to Article 87 to 91 of The Regulation are fulfilled.
Hidden