BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    FreeStyle InsuLinx Blood Glucose Monitoring System

    Reg #: 3007031103 · FEI: 3007031103 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Abbott Ireland Diabetes Care
    Registration Number
    3007031103
    FEI Number
    3007031103
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Donegal Town, Co. Donegal
    City
    Donegal Town
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K152328

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    US Agent

    Business Name
    Abbott Diabetes Care Inc.
    Contact Name
    Rodney Huang
    Address
    1360 South Loop Road
    City
    Alameda
    State
    CA
    ZIP
    94502
    Country
    US
    Email
    [email protected]
    Phone
    510 2392614

    Products

    Device Name Product Code
    Glucose Dehydrogenase, Glucose LFR
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    FreeStyle InsuLinx Blood Glucose Monitoring System

    Establishment Types

    Manufacture Medical Device