BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    SEDECAL S.A.

    Reg #: 9617251 · FEI: 3002495042 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    64
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    SEDECAL S.A.
    Registration Number
    9617251
    FEI Number
    3002495042
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    PELAYA, 9 POL., POL. IND. RIO DE JANEIRO
    City
    ALGETE Madrid (Province)
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K222951

    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 Ave
    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
    System, X-Ray, Stationary KPR
    Generator, High-Voltage, X-Ray, Diagnostic IZO
    Holder, Radiographic Cassette, Wall-Mounted IXY
    Tube Mount, X-Ray, Diagnostic IYB
    Table, Radiographic, Non-Tilting, Powered IZZ
    Table, Radiologic KXJ
    Table, Radiographic, Stationary Top IXQ

    Proprietary Names

    SM-V PhoeniX Odyssey+ Odyssey SPL-HF-4 SPSL-HF-4-APR SPSL-HF-4 SPL-HF-2 NOVA FA SPSLW8 SPSLW4 MOBILETT Impact SPSL8HC SPSL4HC SM-IV Aero DR TX m01 mKDR Xpress Sedecal X Plus Lp Plus (Digital) Sedecal X Plus LP Plus Multi Rad Chiropro Multi Rad NET Millennium Sedecal X Plus Lp Challenge-X SM-40HF-Batt SM-20HF-Batt SM-32HF-Batt SM-50HF-Batt Nova System SHF-XXXX-M SHF-XXX Series SHF-XXXX Series SHF-XXX-C Series SHF-XXXX-C Series SHF-XXXX PSU Series SHFR100,SHFR300,SHFR400,SHFR500,SHFR600,SHFR800 SHF-XXXX-MPSTA SHF-XXX PSU Series Multi RAD MILLENNIUM TWBS-TILT MULT-WBS MILL-WBS MULTIRAD Radiography 7000 M Nova Multirad Millennium Plus FM Plus Mobilett Mira Max Soltus 500 Soltus 450 Multirad NET Proteus XR/f Model ET Proteus XR/f Model ST Mobilett Elara Max Mobilett XP FLEXI DT NET 4000 BRS URS SEMER 001 SEMER 002

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)