2,123 results
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29ms
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Sources: EU EUDAMED, US FDA
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Country: Ireland
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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
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·July 27, 2022
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·July 27, 2022
Cosmo Technologies
Manufacturer
🇮🇪 Ireland·1 Basic UDI-DI·1 Device·ISTITUTO SUPERIORE DI SANITA'
Mirai Medical Limited
Manufacturer
🇮🇪 Ireland·5 Basic UDI-DIs·5 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
CTI-CEM International Limited
Authorized representative
🇮🇪 Ireland
Eleview
Device
EU MDD
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Eu Md Class 2a
·Cosmo Technologies·On the market·17 countries
EPORE Generator
Device
EU MDD
·
Eu Md Class 2a
·Mirai Medical Limited·On the market·7 countries
EPORE Generator
Device
EU MDD
·
Eu Md Class 2a
·Mirai Medical Limited·On the market·7 countries
EPORE Generator
Device
EU MDD
·
Eu Md Class 2a
·Mirai Medical Limited·On the market·7 countries
CUTIS
Device
EU MDD
·
Eu Md Class 2b
·Mirai Medical Limited·On the market·7 countries
EndoVE
Device
EU MDD
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Eu Md Class 2a
·Mirai Medical Limited·On the market·7 countries
Elite SafetyTec Ltd
Importer
🇮🇪 Ireland·19 Manufacturers
Sahajanand Medical Technologies Ireland Limited
Manufacturer
🇮🇪 Ireland·176 Basic UDI-DIs·176 Devices·DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, and DNV Product Assurance AS
Rottapharm Ltd
Manufacturer
🇮🇪 Ireland·18 Basic UDI-DIs·18 Devices·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
QPZ-1956-21
Certificate
MDD Annex V·Cosmo Technologies·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI
Eleview
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Cosmo Technologies·1 device
Creagh Medical Ltd
Manufacturer
🇮🇪 Ireland·72 Basic UDI-DIs·72 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH
OrthoXel DAC
Manufacturer
🇮🇪 Ireland·776 Basic UDI-DIs·786 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.