BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Modius Calm

    Reg #: 3027997270 · FEI: 3027997270 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NEUROVALENS
    Registration Number
    3027997270
    FEI Number
    3027997270
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7 James St South, The Warehouse Floor 4
    City
    Belfast
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K232253

    Owner / Operator

    Firm Name
    Neurovalens
    Operator Number
    10089371
    Address
    651 N. Broad Street, Suite 206
    City
    Middletown
    State
    DE
    Postal Code
    19709
    Country
    US
    Correspondent
    Jason McKeown

    US Agent

    Business Name
    RAF SOLUTIONS USA, INC
    Contact Name
    Edwin Lindsay
    Address
    10124 N.W. 53rd Street, Sunrise
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33351
    Country
    US
    Email
    [email protected]
    Phone
    305 9607262

    Products

    Device Name Product Code
    Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety QJQ

    Proprietary Names

    Modius Calm

    Establishment Types

    Manufacture Medical Device