BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    PRECISION RXi Digital X-ray System

    Reg #: 8020997 · FEI: 3002807092 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GENERAL MEDICAL MERATE S.P.A.
    Registration Number
    8020997
    FEI Number
    3002807092
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA PARTIGIANI, 25
    City
    SERIATE, BERGAMO
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K041605

    Owner / Operator

    Firm Name
    GENERAL MEDICAL MERATE S.P.A.
    Operator Number
    8020997
    Address
    VIA PARTIGIANI, 25, --
    City
    SERIATE, BERGAMO
    State
    IT-NOTA
    Postal Code
    24068
    Country
    IT
    Correspondent
    Luca - Bianchessi

    US Agent

    Business Name
    THEMA CORP
    Contact Name
    Silvia Tamarri
    Address
    2929 Arch Street
    City
    Philadelphia
    State
    PA
    ZIP
    19104
    Country
    US
    Email
    [email protected]
    Phone
    215 8459459

    Products

    Device Name Product Code
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA

    Proprietary Names

    PRECISION RXi Digital X-ray System PRECISION RXi Analog X-ray System

    Establishment Types

    Manufacture Medical Device