35 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Ireland
×
Aerogen Ltd
Manufacturer
🇮🇪 Ireland·5 Basic UDI-DIs·5 Devices·National Standards Authority of Ireland (NSAI)
Medifill Ltd
Manufacturer
🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·National Standards Authority of Ireland (NSAI)
Syncrophi Systems Ltd
Manufacturer
🇮🇪 Ireland·1 Basic UDI-DI·1 Device·National Standards Authority of Ireland (NSAI)
DAU Secondary cut-off Multi-Drug Calibrator
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·1 device
CutisSeal Topical B
Device
EU MDD
·
Eu Md Class 2a
·Medifill Ltd·On the market·1 country
CutisSeal Topical H
Device
EU MDD
·
Eu Md Class 2a
·Medifill Ltd·On the market·1 country
KEWS300
Device
EU MDD
·
Eu Md Class 2b
·Syncrophi Systems Ltd·On the market·1 country
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
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
KEWS300
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Syncrophi Systems Ltd·1 device
CutisSeal Topical B
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Medifill Ltd·1 device
CutisSeal Topical H
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Medifill Ltd·1 device
AG-AS3200
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Aerogen Ltd·1 device