BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    OAF003613

    Reg #: 3004378299 · FEI: 3004378299 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    35
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    QUANTA SYSTEM, S.P.A.
    Registration Number
    3004378299
    FEI Number
    3004378299
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA ACQUEDOTTO, 109
    City
    SAMARATE Varese
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K160513

    Owner / Operator

    Firm Name
    QUANTA SYSTEM, S.P.A.
    Operator Number
    9057522
    Address
    via Acquedotto 109, --
    City
    Samarate
    State
    Varese
    Postal Code
    21017
    Country
    IT
    Correspondent
    Dario Bandiera

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    OAF003613 OAF002703 OAF006013 OAF402713 OAF005513 OAF703603 OAF009903 OAF003603 OAF402013 OAF008013 OAF002013 OAF005503 OAF002003 OAF002713 OAF009913 OAF008003 OAF006003 OAF702793 OAF703693 OAF702703 OAF702713 OAF009912 OAF008012 OAF402712 OAF402012 OAF002012 OAF002712 OAF702712 OAF703612 OAF005512 OAF103613 OAF103693 OAF102793 OAF102713 OAF703613

    Establishment Types

    Manufacture Medical Device