BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    DE GOTZEN S.R.L.

    Reg #: 3002994636 · FEI: 3002994636 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    DE GOTZEN S.R.L.
    Registration Number
    3002994636
    FEI Number
    3002994636
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    STRADA PROVINCIALE BUSTO-CASSANO 3
    City
    FAGNANO OLONA Varese
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K231055

    Owner / Operator

    Firm Name
    DE GOTZEN S.R.L.
    Operator Number
    9012111
    Address
    STRADA PROVINCIALE BUSTO-CASSANO 3
    City
    FAGNANO OLONA
    State
    Varese
    Postal Code
    21054
    Country
    IT

    US Agent

    Business Name
    Acteon, Inc
    Contact Name
    Noelle Zuccarello
    Address
    1001 Briggs Rd
    City
    Mount Laurel
    State
    NJ
    ZIP
    08054
    Country
    US
    Email
    [email protected]
    Phone
    800 2896367 ext. 280

    Products

    Device Name Product Code
    Unit, X-Ray, Extraoral With Timer EHD
    System, Image Processing, Radiological LLZ
    X-Ray, Tomography, Computed, Dental OAS
    System, X-Ray, Extraoral Source, Digital MUH

    Proprietary Names

    x-mind dc Acteon Imaging Suite X-MIND unity X-MIND prime 3D X-MIND optima 3D AIS 3D app RealGUIDE X-MIND prime X-MIND optima U-SENSE U-SENSE HD X-MIND trium

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device