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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Aerogen Ltd — Manufacturer in Ireland

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

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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

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Device catalog for Aerogen Ltd

No devices registered for this manufacturer.

Certificate health for Aerogen Ltd

No certificates registered for this manufacturer.

Statistics for Aerogen Ltd

40Total Devices

16Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

8Countries

Market presence of Aerogen Ltd

Devices placed in 8 countries

Austria28
Ireland5
Cyprus2
Germany1
Denmark1
Estonia1
Croatia1
Poland1

Devices by risk class