BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    BeneCheck Premium GLU Monitoring System

    Reg #: 3008877272 · FEI: 3008877272 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GENERAL LIFE BIOTECHNOLOGY CO., LTD.
    Registration Number
    3008877272
    FEI Number
    3008877272
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6, 7F., No. 669, Jhongjheng Rd., Shin Juang Dist.
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K123090

    Owner / Operator

    Firm Name
    General Life Biotechnology Co., Ltd.
    Operator Number
    10043132
    Address
    7F., No. 669, Jhongjheng Rd., Shin Juang Dist.
    City
    New Taipei City
    State
    TW-NWT
    Postal Code
    242051
    Country
    TW
    Correspondent
    Evonne Chen

    US Agent

    Business Name
    Regulatory Consultant
    Contact Name
    Marissa Vilchez
    Address
    MDSS USA LLC. Chicago, IL 60630, USA
    City
    Chicago
    State
    IL
    ZIP
    60630
    Country
    US
    Email
    [email protected]
    Phone
    312 9751694

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Oxidase, Glucose CGA
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    BeneCheck Premium GLU Monitoring System

    Establishment Types

    Manufacture Medical Device