BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GL DIABETES CORPORATION

    Reg #: 3009129531 · FEI: 3009129531 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    20
    Establishment Types
    3
    Classifications
    6

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    Registration Details

    Registration Name
    GL DIABETES CORPORATION
    Registration Number
    3009129531
    FEI Number
    3009129531
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    9676 Oviedo St
    City
    San Diego
    State
    CA
    ZIP
    92129
    Country
    US

    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
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Glucose Dehydrogenase, Glucose LFR
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Oxidase, Glucose CGA
    Calculator/Data Processing Module, For Clinical Use JQP

    Proprietary Names

    Loris Safety Lancet GoodLife Lancing Device GoodLife Safety Lancet GoodLife Lancet SteriLance Lancing Device GlucoLeader Lancet GlucoLeader Lancing Device Tianjin Huahong Lancet PRECICHEK NS-101 PRECICHEK Cloudia Goodlife AC-300~306 Blood Glucose Monitoring System(NFC) GlucoLeader Value GoodLife AC300~AC305 Blood Glucose Monitoring Sysytem GoodLife AC300~AC305 Professional Blood Glucose Monitoring System Rosie SmartMeter Blood Glucose Monitoring System Goodlife Cs-200 FIA Biomed Salut Blood Glucose Monitoring System FIA Biomed Salut Professional Blood Glucose Monitoring System GL GoodLife Software Fia Blood Glucose Monitoring System (G2)

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device