BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    OMNISCOP Dream-S

    Reg #: 3011347852 · FEI: 3011347852 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    A.T.S. Applicazione Tecnologie Speciali s.r.l.
    Registration Number
    3011347852
    FEI Number
    3011347852
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Alessandro Volta, 10
    City
    Torre de Roveri Bergamo
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K211777

    Owner / Operator

    Firm Name
    SEDECAL S.A.
    Operator Number
    9039772
    Address
    PELAYA, 9 POL., POL. IND. "RIO DE JANEIRO"
    City
    ALGETE
    State
    Madrid (Province)
    Postal Code
    28110
    Country
    ES

    US Agent

    Business Name
    SEDECAL USA, INC
    Contact Name
    Devan Moser
    Address
    7555 N. Caldwell Avenue
    City
    Niles
    State
    IL
    ZIP
    60714
    Country
    US
    Email
    [email protected]
    Phone
    847 3946960

    Products

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

    Proprietary Names

    OMNISCOP Dream-S ARCO FP-S Persona CS Omniscop FP-S AMRAD Medical Agility Cyberbloc FP-S

    Establishment Types

    Manufacture Medical Device