BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    NDR+AND DIVA-D

    Reg #: 3003314115 · FEI: 3003314115 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NICAL SPA
    Registration Number
    3003314115
    FEI Number
    3003314115
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    43 VIA SOFFREDINI
    City
    MILAN (MI) Lombardy
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K053029

    Owner / Operator

    Firm Name
    NICAL SPA
    Operator Number
    9019546
    Address
    43 VIA SOFFREDINI, --
    City
    MILAN (MI)
    State
    IT-NOTA
    Postal Code
    20126
    Country
    IT

    US Agent

    Business Name
    GBS TECHNOLOGIES
    Contact Name
    GERALD SILVERMAN
    Address
    65 Maple St
    City
    Dobbs Ferry
    State
    NY
    ZIP
    10522
    Country
    US
    Email
    [email protected]
    Phone
    914 2757679

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, Image Processing, Radiological LLZ

    Proprietary Names

    NDR+AND DIVA-D SecurScan 500 NFP Digital detector GBS Technologies NICAL

    Establishment Types

    Manufacture Medical Device