BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    The Cooral System

    Reg #: 3014426939 · FEI: 3014426939 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BRAINCOOL AB
    Registration Number
    3014426939
    FEI Number
    3014426939
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Scheelevagen 2
    City
    Lund Skane
    Country
    SE

    Regulatory Submissions

    510(k) Number
    DEN210027

    Owner / Operator

    Firm Name
    BrainCool AB
    Operator Number
    10058195
    Address
    Scheelevagen 2
    City
    Lund
    State
    Skane
    Postal Code
    22381
    Country
    SE
    Correspondent
    Hakan Hummet

    US Agent

    Business Name
    Target Health LLC
    Contact Name
    Adam Harris
    Address
    450 Commerce Blvd
    City
    Carlstadt
    State
    NJ
    ZIP
    07072
    Country
    US
    Email
    [email protected]
    Phone
    212 6812100

    Products

    Device Name Product Code
    Intraoral Cooling Device QUA

    Proprietary Names

    The Cooral System

    Establishment Types

    Manufacture Medical Device