BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIONIME USA CORPORATION

    Reg #: 3006755541 · FEI: 3006755541 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    54
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    BIONIME USA CORPORATION
    Registration Number
    3006755541
    FEI Number
    3006755541
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1450 E. Spruce Street, Bldg. #B
    City
    Ontario
    State
    CA
    ZIP
    91761
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220475

    Owner / Operator

    Firm Name
    BIONIME USA CORPORATION
    Operator Number
    10024947
    Address
    1450 E. Spruce Street, Bldg. #B
    City
    Ontario
    State
    CA
    Postal Code
    91761
    Country
    US

    Products

    Device Name Product Code
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Oxidase, Glucose CGA
    Glucose Dehydrogenase, Glucose LFR
    Calculator/Data Processing Module, For Clinical Use JQP
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    GE Lancet Rightest Lancet Bionime Rightest Blood Glucose Monitoring System RIGHTEST Blood Glucose Monitoring System GM700SB RIGHTEST Blood Glucose Monitoring System GM700S GE Diabetes Management System Bionime Rightest Diabetes Management System Rightest Blood Glucose Monitoring System Rightest Blood Glucose Monitoring System, Model GM100 GE GE100 Blood Glucose Monitoring System Rightest Control Solution GC550 Rightest Control Solution Wiz GE 333 Control Solution McKesson Quintet AC Blood Glucose Test Strip Rightest GM250 Blood Glucose Monitoring System PSS World Medical Quintet AC Blood Glucose Monitoring System GE GM550 Blood Glucose Monitoring System McKesson Quintet AC Control Solution Rightest Blood Glucose Monitoring System, Model GM550 Rightest GM260 Blood Glucose Monitoring System McKesson Quintet AC Blood Glucose Monitoring System Rightest Blood Glucose Monitoring System GT100 Rightest GM250S Blood Glucose Monitoring System GE 300 Talking Blood Glucose Monitoring System GE200 Blood Glucose Monitoring System Rightest Blood Glucose Monitoring System GM650 Rightest Blood Glucose Monitoring System GM700 Rightest Blood Glucose Monitoring System GM280 Diathrive+ Bluetooth Blood Glucose Monitoring System GE Blood Glucose Monitoring System 182 Rightest Blood Glucose Monitoring System GM280B GE Blood Glucose Monitoring System 180 Diathrive+ Blood Glucose Monitoring System GE300 Talking Blood Glucose Monitoring System RIGHTEST Lancing Device GD500 iGlucose Lancing Device GE Lancing Device GE Blood Glucose Monitoring System 333 Rightest Blood Glucose Monitoring System GT333 Rightest Blood Glucose Monitoring System GM232 GE Blood Glucose Monitoring System Wiz Plus Rightest Blood Glucose Monitoring System Wiz Rightest Blood Glucose Monitoring System Wiz Plus GE Blood Glucose Monitoring System Wiz Rightest Blood Glucose Monitoring System Max Rightest Blood Glucose Monitoring System Max Plus GE Blood Glucose Monitoring System Max GE Blood Glucose Monitoring System Max Plus Rightest Blood Glucose Monitoring System Max Tel Rightest Control Solution GC310 Rightest Control Solution GC110 Rightest Control Solution GC300 Rightest Control Solution GC100 Rightest Blood Glucose Monitoring System GM720

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198