BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    FreeStyle Libre 3 Continuous Glucose Monitoring System

    Reg #: 3033394445 · FEI: 3033394445 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Abbott Ireland, ADC Kilkenny
    Registration Number
    3033394445
    FEI Number
    3033394445
    Status
    Active
    Expiry Year
    2025
    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

    Proprietary Names

    FreeStyle Libre 3 Continuous Glucose Monitoring System

    Establishment Types

    Manufacture Medical Device