BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Flextronics International USA

    Reg #: 3011536730 · FEI: 3011536730 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    6

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    Registration Details

    Registration Name
    Flextronics International USA
    Registration Number
    3011536730
    FEI Number
    3011536730
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    700 Corporate Grove Drive
    City
    Buffalo Grove
    State
    IL
    ZIP
    60089
    Country
    US

    Owner / Operator

    Firm Name
    Flextronics International USA, Inc.
    Operator Number
    9006592
    Address
    12455 Research Blvd
    City
    Austin
    State
    TX
    Postal Code
    78759
    Country
    US
    Correspondent
    Chad Ashton

    Products

    Device Name Product Code
    Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems QLG
    System, Test, Blood Glucose, Over The Counter NBW
    Integrated Continuous Glucose Monitoring System, Factory Calibrated QBJ
    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated PZE
    Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter SBH
    Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter SAF

    Proprietary Names

    FreeStyle Libre 3 Reader Kits FreeStyle Libre 2 Reader Kits Instinct Sensor FreeStyle Libre 2 Plus Sensor Kits FreeStyle Libre 3 Plus Sensor Kits FreeStyle Libre 3 Continuous Glucose Monitoring System FreeStyle Libre 2 Flash Glucose Monitoring System FreeStyle Libre Flash Glucose Monitoring System Freestyle Libre 2 Flash Glucose Monitoring System Libre Rio Continuous Glucose Monitoring System Lingo Glucose System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only