BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GoodLife AC300~AC305 Blood Glucose Monitoring Sysytem

    Reg #: 3009129531 · FEI: 3009129531 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GL DIABETES CORPORATION
    Registration Number
    3009129531
    FEI Number
    3009129531
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9676 Oviedo St
    City
    San Diego
    State
    CA
    ZIP
    92129
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113307

    Owner / Operator

    Firm Name
    GL DIABETES CORPORATION
    Operator Number
    10035802
    Address
    9676 Oviedo St.
    City
    San Diego
    State
    CA
    Postal Code
    92129
    Country
    US
    Correspondent
    Tina Jair

    Products

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

    Proprietary Names

    GoodLife AC300~AC305 Blood Glucose Monitoring Sysytem Rosie SmartMeter Blood Glucose Monitoring System GoodLife AC300~AC305 Professional Blood Glucose Monitoring System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)