BEUDAMED
    FDA Registration Active 🇨🇳 China

    Freestyle Libre 2 Flash Glucose Monitoring System

    Reg #: 3007421145 · FEI: 3004173703 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd.
    Registration Number
    3007421145
    FEI Number
    3004173703
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-6/F, Building 1, 3B/F, 4/F, Building 2, and 5-7/F, Building 3, Rundongsheng Industrial Park, Longteng, Xixiang, Baoan District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K193371

    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

    US Agent

    Business Name
    FLEXTRONICS INTERNATIONAL USA, INC.
    Contact Name
    Chad Ashton
    Address
    12455 Research Blvd
    City
    Austin
    State
    TX
    ZIP
    78759
    Country
    US
    Email
    [email protected]
    Phone
    901 8712423

    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

    Proprietary Names

    Freestyle Libre 2 Flash Glucose Monitoring System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)