BEUDAMED
    FDA Registration Active 🇫🇷 France

    D2RS

    Reg #: 3006972752 · FEI: 3006972752 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Stephanix
    Registration Number
    3006972752
    FEI Number
    3006972752
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10 Rue Jean Moulin
    City
    La Ricamarie Auvergne-Rhone-Alpes
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K221335

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

    Proprietary Names

    D2RS D2RS9090 D2RS_AT_PA D2RS_9090_AT_PA D2RS_AT_PA_NV2 D2RS_9090_AT_PA_NV2

    Establishment Types

    Manufacture Medical Device