31 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Ireland
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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)
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
ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·December 3, 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
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