18 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Ireland
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SW Navios EX v2.1
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Ireland Inc.·On the market·32 countries
(6C 2L ) Navios EX Instrument
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Ireland Inc.·On the market·32 countries
(8C 2L) Navios EX Instrument
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Ireland Inc.·On the market·32 countries
(10C 3L) Navios EX Instrument
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Ireland Inc.·On the market·32 countries
SW offline New user (Navios EX)
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Ireland Inc.·On the market·32 countries
SW offline 5 users (Navios EX)
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Ireland Inc.·On the market·32 countries
SW Acquisition New User (Navios EX)
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Ireland Inc.·On the market·32 countries
LENNOX HILL 3 PANEL IMMOB EX LARGE
Device
EU MDR
·
Eu Md Class 1
·Trulife·On the market
WRAP AROUND HINGED KNEE SUPP EX LARGE
Device
EU MDR
·
Eu Md Class 1
·Trulife·On the market
SW Kit; Navios EX Single User (Win 10)
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Ireland Inc.·On the market·32 countries
SW Kit; Navios EX Offline 5 Users (Win 10)
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Ireland Inc.·On the market·32 countries
Navios EX Instrument & Software
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Ireland Inc.·10 devices
ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·February 13, 2019
ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·February 13, 2019
Abbott Rapid Dx International Limited
Importer
🇮🇪 Ireland·11 Manufacturers
Care Surgical Supplies Limited
Authorized representative
🇮🇪 Ireland·2 Manufacturers·371 Devices
Abbott Rapid Dx International Limited
Authorized representative
🇮🇪 Ireland·5 Manufacturers·4 Devices
Eurolink Europe Compliance Limited
Authorized representative
🇮🇪 Ireland·35 Manufacturers·252 Devices