20 results
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41ms
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Sources: EU EUDAMED, US FDA
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Country: Ireland
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Aerogen Ltd
Manufacturer
🇮🇪 Ireland·5 Basic UDI-DIs·5 Devices·National Standards Authority of Ireland (NSAI)
AEROGEN LTD
FDA registration
AEROGEN LTD·3 products·🇮🇪 Ireland
AEROGEN LTD.
FDA registration
AEROGEN LTD.·3 products·🇮🇪 Ireland
Aerogen USB Controller
Device
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·On the market·7 countries
Aerogen USB Controller
Device
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·On the market·1 country
Aerogen Ultra (10 Pack)
Device
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·On the market·1 country
Aerogen Solo Adult T-Piece 22mm
Device
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·On the market·13 countries
Aerogen Solo Nebuliser (10 Pack)
Device
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·On the market·25 countries
AG-AS3200
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·1 device
AG-AS3010
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·1 device
AG-UC1000-NE
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·1 device
AG-UC1000-IN
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·1 device
AG-AS7000-EU
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·1 device
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
FDA Enforcement
Class II
·Terminated·Aerogen Ltd.·October 29, 2014
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
FDA Enforcement
Class II
·Terminated·Aerogen Ltd.·October 29, 2014
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
FDA Enforcement
Class II
·Terminated·Aerogen Ltd.·October 29, 2014
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
FDA Enforcement
Class II
·Terminated·Aerogen Ltd.·October 29, 2014
Aerogen Ltd
Importer
🇮🇪 Ireland
252.509
Certificate
MDD Annex II (excluding section 4)·Aerogen Ltd·National Standards Authority of Ireland (NSAI)·5 Basic UDI-DIs
Aerogen Ltd.
System producer
🇮🇪 Ireland