BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    GILARDONI S.P.A.

    Reg #: 8043725 · FEI: 3009631751 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GILARDONI S.P.A.
    Registration Number
    8043725
    FEI Number
    3009631751
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA ARTURO GILARDONI, 1
    City
    MANDELLO DEL LARIO Lecco
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K201177

    Owner / Operator

    Firm Name
    GILARDONI S.p.A.
    Operator Number
    9003480
    Address
    via A. Gilardoni 1
    City
    Mandello del Lario
    State
    Lecco
    Postal Code
    23826
    Country
    IT
    Correspondent
    Daniele - Maggioni

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Dr
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Generator, High-Voltage, X-Ray, Diagnostic IZO
    Irradiator, Blood To Prevent Graft Versus Host Disease MOT
    Assembly, Tube Housing, X-Ray, Diagnostic ITY

    Proprietary Names

    IXION III HF GENERATOR RADGIL2 US IXION MONOBLOCK

    Establishment Types

    Manufacture Medical Device