BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Helianthus

    Reg #: 3009868110 · FEI: 3009868110 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Metaltronica Spa
    Registration Number
    3009868110
    FEI Number
    3009868110
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Pomezia (RM) via delle Monachelle 66
    City
    Pomezia Roma
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K202822

    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 7618675

    Products

    Device Name Product Code
    Full Field Digital, System, X-Ray, Mammographic MUE

    Proprietary Names

    Helianthus

    Establishment Types

    Manufacture Medical Device