BEUDAMED
    FDA Registration Active 🇫🇷 France

    BRIGHTHEART SAS

    Reg #: 3034527804 · FEI: 3034527804 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BRIGHTHEART SAS
    Registration Number
    3034527804
    FEI Number
    3034527804
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7-11 boulevard Haussmann
    City
    Paris
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K242342

    Owner / Operator

    Firm Name
    BrightHeart
    Operator Number
    10092243
    Address
    7-11 boulevard Haussmann
    City
    Paris
    State
    FR-75
    Postal Code
    75009
    Country
    FR
    Correspondent
    Christophe Gardella

    US Agent

    Business Name
    Medicsense USA LLC
    Contact Name
    George Hattub
    Address
    291 Hillside Ave
    City
    Somerset
    State
    MA
    ZIP
    02726
    Country
    US
    Email
    [email protected]
    Phone
    508 4996116

    Products

    Device Name Product Code
    Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer POK
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    B-Right Screen Fetal Heart Fetal EchoScan B-Right Views Fetal Heart BrightHeart View Classifier

    Establishment Types

    Manufacture Medical Device