BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    DS-A Blood Glucose Monitoring Syste

    Reg #: 3006532271 · FEI: 3006532271 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ALLIANCE INTERNATIONAL MEDICAL CO., LTD.
    Registration Number
    3006532271
    FEI Number
    3006532271
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.54, Yingtao Rd., Yingge Dist.
    City
    NEW TAIPEI CITY
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K082965

    Owner / Operator

    Firm Name
    ALLIANCE INTERNATIONAL MEDICAL CO., LTD.
    Operator Number
    9099902
    Address
    No.54, Yingtao Rd., Yingge Dist.
    City
    New Taipei City
    State
    TW-NWT
    Postal Code
    23942
    Country
    TW

    US Agent

    Business Name
    ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
    Contact Name
    SHU-CHEN CHENG
    Address
    2064 TAMARIN DRIVE
    City
    COLUMBUS
    State
    OH
    ZIP
    43235
    Country
    US
    Email
    [email protected]
    Phone
    614 5888168

    Products

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

    Proprietary Names

    DS-A Blood Glucose Monitoring Syste

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device