BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Dario Blood Glucose Monitoring System

    Reg #: 3010606081 · FEI: 3010606081 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    LABSTYLE INNOVATIONS
    Registration Number
    3010606081
    FEI Number
    3010606081
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 Tarshish St., Northern Industrial Park
    City
    Caesarea Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K150817

    Owner / Operator

    Firm Name
    LabStlyle Innovation
    Operator Number
    10045467
    Address
    5 Tarshish Street, Caesarea North Industrial Park
    City
    Caesarea
    State
    IL-NOTA
    Postal Code
    3079821
    Country
    IL
    Correspondent
    Mona Dean

    US Agent

    Business Name
    Dario Health
    Contact Name
    Mona Dean
    Address
    322 W 57th St Apt 33b
    City
    New York
    State
    NY
    ZIP
    10019
    Country
    US
    Email
    [email protected]
    Phone
    913 6381954

    Products

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

    Proprietary Names

    Dario Blood Glucose Monitoring System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility