BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    IDS-iSYS Cartridge Check System (CCS)

    Reg #: 3007500635 · FEI: 3007500635 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Immunodiagnostic Systems SA
    Registration Number
    3007500635
    FEI Number
    3007500635
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rue Ernest Solvay 101
    City
    Liege
    Country
    BE

    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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    IDS-iSYS Cartridge Check System (CCS) IDS-iSYS D-Sorb Solution IDS-iSYS Cuvettes IDS Immunocleaner IDS-iSYS Wash Solution (Wash S) IDS-iSYS Trigger Set IDS-iSYS System Liquid (Syst l)

    Establishment Types

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