BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    GI Genius™ Module 200

    Reg #: 3016432796 · FEI: 3016432796 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MB Elettronica S.r.l.
    Registration Number
    3016432796
    FEI Number
    3016432796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zona Ind.le C.S. Ossaia, 35-35/P
    City
    Cortona Arezzo
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K241887

    Owner / Operator

    Firm Name
    MB ELETTRONICA
    Operator Number
    10080933
    Address
    P.I.P. Vallone, 35 Camucia
    City
    Cortona
    State
    Arezzo
    Postal Code
    52044
    Country
    IT

    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™ Module 200 GI Genius™ Module 100 GI Genius™ Module 300

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)