BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    Aero DR TX m01

    Reg #: 9617251 · FEI: 3002495042 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SEDECAL S.A.
    Registration Number
    9617251
    FEI Number
    3002495042
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PELAYA, 9 POL., POL. IND. RIO DE JANEIRO
    City
    ALGETE Madrid (Province)
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K221803

    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
    System, X-Ray, Mobile IZL
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    Aero DR TX m01 mKDR Xpress

    Establishment Types

    Manufacture Medical Device