BEUDAMED
    FDA Registration Active 🇫🇷 France

    IMMUNODIAGNOSTIC SYSTEMS FRANCE SAS

    Reg #: 9615777 · FEI: 3007034602 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    IMMUNODIAGNOSTIC SYSTEMS FRANCE SAS
    Registration Number
    9615777
    FEI Number
    3007034602
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    42 Rue Stephane Mazeau
    City
    POUILLY EN AUXOIS Cote-d'Or
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K161831

    Owner / Operator

    Firm Name
    IMMUNODIAGNOSTIC SYSTEMS LTD.
    Operator Number
    8021924
    Address
    10 DIDCOT WAY, BOLDON BUSINESS PARK
    City
    BOLDON COLLIERY
    State
    GB-NOTA
    Postal Code
    NE35 9PD
    Country
    GB

    US Agent

    Business Name
    Euroimmun US Inc.
    Contact Name
    Faith Du
    Address
    1 Bloomfield Avenue, Mountain Lakes
    City
    Mountain Lakes
    State
    NJ
    ZIP
    07046
    Country
    US
    Email
    [email protected]
    Phone
    800 9132022

    Products

    Device Name Product Code
    System, Test, Vitamin D MRG
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    IDS-iSYS 25 VitDS Control Set IDS-iSYS 25 VitDS

    Establishment Types

    Manufacture Medical Device