BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    GI Genius™ System 100

    Reg #: 3018899987 · FEI: 3018899987 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COSMO ARTIFICIAL INTELLIGENCE, LTD
    Registration Number
    3018899987
    FEI Number
    3018899987
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Riverside II, Sir John Rogerson's Quay
    City
    Dublin 2
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K231143

    Owner / Operator

    Firm Name
    Cosmo Artificial Intelligence, Ltd
    Operator Number
    10081320
    Address
    Riverside II, Sir John Rogerson's Quay
    City
    Dublin 2
    State
    IE-D
    Postal Code
    D02 KV60
    Country
    IE

    US Agent

    Business Name
    Conventus Biomedical Solutions, Inc.
    Contact Name
    Steven Kradjian
    Address
    9920 Pacific Heights Blvd, Suite 150
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    858 4012111

    Products

    Device Name Product Code
    Gastrointesinal Lesion Software Detection System QNP

    Proprietary Names

    GI Genius™ System 100 GI Genius™ System 200 USB K-switch Footswitch

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device