BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    SEE FACTOR CT3

    Reg #: 3012957335 · FEI: 3012957335 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Imaginalis S.r.l.
    Registration Number
    3012957335
    FEI Number
    3012957335
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Rodolfo Morandi, 13-15
    City
    Sesto Fiorentino Firenze
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K233230

    Owner / Operator

    Firm Name
    Epica International
    Operator Number
    10078585
    Address
    19810 Asheville Hwy
    City
    Landrum
    State
    SC
    Postal Code
    29356
    Country
    US
    Correspondent
    Craig Glaiberman

    US Agent

    Business Name
    Epica International, Inc.
    Contact Name
    Craig Glaiberman
    Address
    19810 Asheville Hwy
    City
    Landrum
    State
    SC
    ZIP
    29356
    Country
    US
    Email
    [email protected]
    Phone
    916 8505866

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK
    Interventional Fluoroscopic X-Ray System OWB

    Proprietary Names

    SEE FACTOR CT3

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198