BEUDAMED
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    Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·April 24, 2024

    Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·April 3, 2024

    Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·May 15, 2024

    Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·April 24, 2024

    Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·August 16, 2023

    NEO HEALTHIES LIMITED

    Authorized representative
    🇮🇪 Ireland·4 Manufacturers·9 Devices

    Meridius Medical Europe Limited

    Authorized representative
    🇮🇪 Ireland·36 Manufacturers·720 Devices

    Boston Scientific Limited

    Importer
    🇮🇪 Ireland·15 Manufacturers