BEUDAMED
    5 results · 15ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Country: Ireland ×

    Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351

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

    Metaphysis (Ireland) Ltd

    Authorized representative
    🇮🇪 Ireland·1 Manufacturer·4 Devices

    Cook Ireland

    Importer
    🇮🇪 Ireland·3 Manufacturers

    Cook Medical Europe Ltd

    Importer
    🇮🇪 Ireland·9 Manufacturers

    International Associates Auditing & Certification Limited

    Authorized representative
    🇮🇪 Ireland·46 Manufacturers·161 Devices