BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Brainreader

    Reg #: 3011657336 · FEI: 3011657336 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Brainreader
    Registration Number
    3011657336
    FEI Number
    3011657336
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Niels Jernes Vej 10
    City
    Aalborg Nordjylland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K140828

    Owner / Operator

    Firm Name
    Brainreader A/S
    Operator Number
    10049047
    Address
    Niels Jernes Vej 10
    City
    Aalborg
    State
    Nordjylland
    Postal Code
    9220
    Country
    DK
    Correspondent
    Basant K Bajpai

    US Agent

    Business Name
    Brainreader
    Contact Name
    Kimberly Henry
    Address
    One Urban Center, 4830 W Kennedy Blvd
    City
    Tampa
    State
    FL
    ZIP
    33609
    Country
    US
    Email
    [email protected]
    Phone
    954 4054775

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    Neuroreader®

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility