BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GE300 Talking Blood Glucose Monitoring System

    Reg #: 3006755541 · FEI: 3006755541 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIONIME USA CORPORATION
    Registration Number
    3006755541
    FEI Number
    3006755541
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1450 E. Spruce Street, Bldg. #B
    City
    Ontario
    State
    CA
    ZIP
    91761
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123008

    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
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Dehydrogenase, Glucose LFR

    Proprietary Names

    GE300 Talking Blood Glucose Monitoring System GE200 Blood Glucose Monitoring System Rightest Blood Glucose Monitoring System GM650 Rightest Blood Glucose Monitoring System GM700

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198