BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    GI Genius™ Module 300

    Reg #: 3018901422 · FEI: 3018901422 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LINKVERSE S.R.L.
    Registration Number
    3018901422
    FEI Number
    3018901422
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Ostiense 131L
    City
    Roma
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K241887

    Owner / Operator

    Firm Name
    Linkverse s.r.l.
    Operator Number
    10081308
    Address
    Via Ostiense 131L
    City
    Roma
    State
    IT-RM
    Postal Code
    00154
    Country
    IT

    US Agent

    Business Name
    Conventus Biomedical Solutions
    Contact Name
    Steve 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™ Module 300 GI Genius™ Module 200 ColonPRO™ 4 (CPRO40.US) GI Genius™ Module 100 ColonPRO™ 4 (CPRO40S-US)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility