BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Abbott Ireland, ADC Kilkenny

    Reg #: 3033394445 · FEI: 3033394445 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Abbott Ireland, ADC Kilkenny
    Registration Number
    3033394445
    FEI Number
    3033394445
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    IDA Ireland Kilkenny Business & Technology Park, Ring Road
    City
    Kilkenny
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K222447

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    US Agent

    Business Name
    ABBOTT LABORATORIES
    Contact Name
    Rodney Huang
    Address
    1360 S Loop Rd
    City
    Alameda
    State
    CA
    ZIP
    94502
    Country
    US
    Email
    [email protected]
    Phone
    510 2392614

    Products

    Device Name Product Code
    Integrated Continuous Glucose Monitoring System, Factory Calibrated QBJ
    System, Test, Blood Glucose, Over The Counter NBW
    Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems QLG

    Proprietary Names

    FreeStyle Libre 3 Continuous Glucose Monitoring System FreeStyle Libre 2 Flash Glucose Monitoring System Instinct sensor

    Establishment Types

    Manufacture Medical Device