BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EUROIMMUN Analyzer I

    Reg #: 3007118747 · FEI: 3007118747 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EUROIMMUN US INC.
    Registration Number
    3007118747
    FEI Number
    3007118747
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1 Bloomfield Ave
    City
    Mountain Lakes
    State
    NJ
    ZIP
    07046
    Country
    US

    Owner / Operator

    Firm Name
    EUROIMMUN US Inc.
    Operator Number
    10025673
    Address
    1 Bloomfield Ave.
    City
    Mountain Lakes
    State
    NJ
    Postal Code
    07046
    Country
    US

    Products

    Device Name Product Code
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    EUROIMMUN Analyzer I EUROIMMUN Analyzer I-2P IF Sprinter Sprinter XL EUROLabWorkstation ELISA EUROBlotOne Device Qualification Test Kit EUROLabLiquidHandler IDS-iSYS D-Sorb Solution IDS-iSYS Cartridge Check System (CCS) IDS-iSYS Wash Solution (Wash S) IDS-iSYS Trigger Set System liquid concentrate Device Qualification Test Kit EUROLabWorkstation ELISA Device Qualification Test Kit EUROLabWorkstation IFA IDS Top Cap Set IDS-iSYS System Liquid (Syst l) Device Qualification Test Kit EUROIMMUN Analyzer I / I-2P IDS Immunocleaner IDS-iSYS Cuvettes

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198