BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    NOVAC 11

    Reg #: 3010625741 · FEI: 3010625741 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SIT SORDINA IORT TECHNOLOGIES SPA
    Registration Number
    3010625741
    FEI Number
    3010625741
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    via dell'industria 1/a
    City
    aprilia Latina
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K112286

    Owner / Operator

    Firm Name
    SIT-Sordina IORT Technologies SpA
    Operator Number
    10043521
    Address
    Via dell'Innovazione, 5-7
    City
    Grisignano di Zocco
    State
    Vicenza
    Postal Code
    36040
    Country
    IT
    Correspondent
    Veronica De Liso

    US Agent

    Business Name
    MEDAGENT Inc.
    Contact Name
    Franz Menean
    Address
    264 Lafayette Rd Ste 7
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US
    Email
    [email protected]
    Phone
    603 5702039

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE

    Proprietary Names

    NOVAC 11 ABSORBER SHIELDING

    Establishment Types

    Manufacture Medical Device