BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    GE200 glucose monitoring system

    Reg #: 3004183148 · FEI: 3004183148 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIONIME CORPORATION
    Registration Number
    3004183148
    FEI Number
    3004183148
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO. 100, Sec. 2, Daqing St., South Dist.
    City
    Taichung City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K141292

    Owner / Operator

    Firm Name
    BIONIME CORPORATION
    Operator Number
    9059262
    Address
    NO. 100, Sec. 2, Daqing St., SOUTH DIST.
    City
    TAICHUNG CITY
    State
    TW-NOTA
    Postal Code
    40242
    Country
    TW

    Products

    Device Name Product Code
    Glucose Dehydrogenase, Glucose LFR
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    GE200 glucose monitoring system

    Establishment Types

    Manufacture Medical Device