BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    NewTom 5G XL

    Reg #: 3006610845 · FEI: 3006610845 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CEFLA S.C.
    Registration Number
    3006610845
    FEI Number
    3006610845
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA BICOCCA 14/C
    City
    IMOLA Bologna
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K183448

    Owner / Operator

    Firm Name
    CEFLA S.C.
    Operator Number
    9057266
    Address
    Via Bicocca 14/C
    City
    Imola
    State
    Bologna
    Postal Code
    40026
    Country
    IT

    US Agent

    Business Name
    Cefla North America Inc
    Contact Name
    Brett Power
    Address
    6125 Harris Technology Blvd
    City
    Charlotte
    State
    NC
    ZIP
    28269
    Country
    US
    Email
    [email protected]
    Phone
    704 7315249

    Products

    Device Name Product Code
    X-Ray, Tomography, Computed, Dental OAS
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    NewTom 5G XL

    Establishment Types

    Manufacture Medical Device