BEUDAMED
    FDA Registration Active 🇫🇷 France

    Stephanix

    Reg #: 3006972752 · FEI: 3006972752 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Stephanix
    Registration Number
    3006972752
    FEI Number
    3006972752
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10 Rue Jean Moulin
    City
    La Ricamarie Auvergne-Rhone-Alpes
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K213479

    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, Angiographic IZI
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA

    Proprietary Names

    D2RS9090 D2RS D2RS_9090_B1_N D2RS_B1_NV2 D2RS_9090_B1_NV2 D2RS_B1_N D2RS_AT_PA_NV2 D2RS_9090_AT_PA_NV2 D2RS_9090_AT_PA D2RS_AT_PA

    Establishment Types

    Manufacture Medical Device