BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IFA 40: HEp-20-10 EUROPattern

    Reg #: 3007118747 · FEI: 3007118747 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    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

    Regulatory Submissions

    510(k) Number
    K141827

    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
    Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control DHN
    Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use PIV

    Proprietary Names

    IFA 40: HEp-20-10 EUROPattern EUROPattern Classifier EUROPattern Microscope

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)