BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    BIONIME CORPORATION

    Reg #: 3004183148 · FEI: 3004183148 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    50
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    BIONIME CORPORATION
    Registration Number
    3004183148
    FEI Number
    3004183148
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    NO. 100, Sec. 2, Daqing St., South Dist.
    City
    Taichung City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K092052

    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 Oxidase, Glucose CGA
    System, Test, Blood Glucose, Over The Counter NBW
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Glucose Dehydrogenase, Glucose LFR

    Proprietary Names

    McKesson Quintet AC Blood Glucose Test Strip McKesson Quintet AC Control Solution McKesson Quintet AC Blood Glucose Monitoring System Rightest Blood Glucose Monitoring System, Model GM550 GE GE100 Blood Glucose Monitoring System Rightest Control Solution GC550 Rightest GM250 Blood Glucose Monitoring System Rightest Blood test Glucose monitoring System GM100 RIGHTEST Blood Test Strip GS100 iGlucose Blood Glucose Monitoring System iGlucose Plus Blood Glucose Monitoring System iGlucose Blood Glucose Test Strip Rightest Blood Glucose Monitoring System GT333 Rightest Blood Glucose Monitoring System GM232 RIGHTEST GT333 Blood Glucose Test Strip RIGHTEST Lancing Device GD500 GE Lancing Device iGlucose Lancing Device Rightest Blood Glucose Test Strip GS300 Rightest Blood Glucose Monitoring System GM300 Rightest Control Solution GC110 Rightest Control Solution GC100 Rightest Control Solution GC310 Rightest Control Solution GC300 RIGHTEST GT333 Control Solution GE200 glucose monitoring system RIGHTEST Blood glucose monitoring System Max Tel iGlucose Touch Control Solution GC700 iGlucose Touch Blood Glucose Test Strips iGlucose Touch Blood Glucose Monitoring System iGlucose Touch Blood Glucose Meter RIGHTEST Blood glucose meter Max Tel RIGHTEST Blood glucose test strip Max RIGHTEST Control Solution GC700 GE Blood Glucose Monitoring System 180 Rightest Blood Glucose Monitoring System GM280 GE Blood Glucose Monitoring System 182 Rightest Blood Glucose Monitoring System GM280B Diathrive+ Bluetooth Blood Glucose Monitoring System Diathrive+ Blood Glucose Monitoring System GE GlucoCapture Cielo Plus Blood Glucose Monitoring System GE GlucoCapture Cielo Blood Glucose Monitoring System Diathrive Blood Glucose Test Strip RIGHTEST Blood Glucose Monitoring System GM700S RIGHTEST Blood Glucose Monitoring System GM700SB Rightest Blood Glucose Monitoring System Max Rightest Blood Glucose Monitoring System Max Plus GE Blood Glucose Monitoring System Max Plus GE Blood Glucose Monitoring System Max GE Blood Glucose Test Strip Max

    Establishment Types

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