BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FreeStyle Libre 3 Continuous Glucose Monitoring System

    Reg #: 3006537560 · FEI: 3006537560 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Flextronics America, LLC
    Registration Number
    3006537560
    FEI Number
    3006537560
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12455 Research Boulevard
    City
    Austin
    State
    TX
    ZIP
    78759
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222447

    Owner / Operator

    Firm Name
    Flextronics International USA, Inc.
    Operator Number
    9006592
    Address
    6201 America Center Drive
    City
    San Jose
    State
    CA
    Postal Code
    95002
    Country
    US
    Correspondent
    Chad Ashton

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Integrated Continuous Glucose Monitoring System, Factory Calibrated QBJ

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)