BEUDAMED
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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

    CTI-CEM International Limited

    Authorized representative
    🇮🇪 Ireland

    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

    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.

    Mainstay Medical Limited

    Manufacturer
    🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V.

    PMD Device Solutions Ltd

    Manufacturer
    🇮🇪 Ireland·2 Basic UDI-DIs·5 Devices·SGS Belgium NV

    Aerogen Ltd

    Manufacturer
    🇮🇪 Ireland·5 Basic UDI-DIs·5 Devices·National Standards Authority of Ireland (NSAI)

    AventaMed DAC

    Manufacturer
    🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V.

    Idoman Teoranta

    Manufacturer
    🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·SGS Belgium NV

    Mirai Medical Limited

    Manufacturer
    🇮🇪 Ireland·5 Basic UDI-DIs·5 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

    Spinal Stabilization Technologies, Ltd

    Manufacturer
    🇮🇪 Ireland·1 Basic UDI-DI·1 Device·GMED SAS

    Syncrophi Systems Ltd

    Manufacturer
    🇮🇪 Ireland·1 Basic UDI-DI·1 Device·National Standards Authority of Ireland (NSAI)

    G7 038830 0030

    Certificate
    MDD Annex II Section 4·Rottapharm Ltd·TÜV SÜD Product Service GmbH·5 Basic UDI-DIs

    G7 038830 0030

    Certificate
    MDD Annex II Section 4·Rottapharm Ltd·TÜV SÜD Product Service GmbH·11 Basic UDI-DIs