BEUDAMED
    FDA Registration Active 🇳🇴 Norway

    nordicICE

    Reg #: 3006738448 · FEI: 3006738448 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NORDICNEUROLAB AS
    Registration Number
    3006738448
    FEI Number
    3006738448
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MOLLENDALSVEIEN 1
    City
    BERGEN Hordaland
    Country
    NO

    Regulatory Submissions

    510(k) Number
    K090546

    Owner / Operator

    Firm Name
    NORDICNEUROLAB AS
    Operator Number
    9098320
    Address
    MOLLENDALSVEIEN 1, --
    City
    BERGEN
    State
    Hordaland
    Postal Code
    5009
    Country
    NO

    US Agent

    Business Name
    NordicNeuroLab Inc.
    Contact Name
    Cathy Elsinger
    Address
    234 W Florida St Ste 202
    City
    Milwaukee
    State
    WI
    ZIP
    53204
    Country
    US
    Email
    [email protected]
    Phone
    262 3370922

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    nordicICE Perfusion Module nordicICE Perfusion/DCE module nordicBrainEx

    Establishment Types

    Manufacture Medical Device