2,704 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Ireland
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ISE Na+/K+ Selectivity Check
Device
EU IVDR
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Eu Ivd Class B
·Beckman Coulter Ireland Inc.·On the market·32 countries
ISE Na+/K+ Selectivity Check
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Beckman Coulter Ireland Inc.·1 device
FILTERTEK, B.V. (AN ITW MEDICAL COMPANY)
FDA registration
FILTERTEK, B.V. (AN ITW MEDICAL COMPANY)·1 product·🇮🇪 Ireland
a-1-ANTITRYPSIN
Device
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·On the market·32 countries
A Supreme Left Size 1
Device
EU MDR
·
Eu Md Class 1
·Trulife·On the market·19 countries
A Supreme Right Size 1
Device
EU MDR
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Eu Md Class 1
·Trulife·On the market·19 countries
Silk A Supreme Right Size 1
Device
EU MDR
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Eu Md Class 1
·Trulife·On the market·19 countries
Silk A Supreme Left Size 1
Device
EU MDR
·
Eu Md Class 1
·Trulife·On the market·19 countries
PMD Device Solutions Ltd
Manufacturer
🇮🇪 Ireland·2 Basic UDI-DIs·5 Devices·SGS Belgium NV
Stafford-Miller (Ireland) Limited
Manufacturer
🇮🇪 Ireland·SGS Belgium NV
Idoman Teoranta
Manufacturer
🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·SGS Belgium NV
BOSTON SOFT AFO W/O STABILIZER SIZE ADULT A (1-2)
Device
EU MDR
·
Eu Md Class 1
·Allard Support UK Ltd·On the market
a-1 ANTITRYPSIN
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·1 device
RespiraSense
Device
EU MDD
·
Eu Md Class 2b
·PMD Device Solutions Ltd·On the market·1 country
Thermablate EAS
Device
EU MDD
·
Eu Md Class 2b
·Idoman Teoranta·On the market·16 countries
Thermablate EAS
Device
EU MDD
·
Eu Md Class 2b
·Idoman Teoranta·On the market·17 countries
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·September 28, 2022
RespiraSense patient respiratory monitor system
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·PMD Device Solutions Ltd·1 device
Thermablate EAS Treatment Control Unit
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Idoman Teoranta·1 device
Thermablate EAS Disposable Cartridge
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Idoman Teoranta·1 device