BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    EUROLINE ENA Profile 9 Ag (IgG)

    Reg #: 3003268355 · FEI: 3003268355 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
    Registration Number
    3003268355
    FEI Number
    3003268355
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    EUROIMMUN AG, Seekamp 31
    City
    Luebeck Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K140224

    Owner / Operator

    Firm Name
    EUROIMMUN Medizinische Labordiagnostika AG
    Operator Number
    10025212
    Address
    EUROIMMUN AG, Seekamp 31
    City
    Luebeck
    State
    Schleswig-Holstein
    Postal Code
    D-23560
    Country
    DE
    Correspondent
    Stephan Maihold

    Products

    Device Name Product Code
    Anti-Ribosomal P Antibodies MQA
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
    Extractable Antinuclear Antibody, Antigen And Control LLL
    Anti-Sm Antibody, Antigen And Control LKP
    Anti-Rnp Antibody, Antigen And Control LKO

    Proprietary Names

    EUROLINE ENA Profile 9 Ag (IgG) EUROLINE ENA ProfilePlus 4 (IgG)

    Establishment Types

    Manufacture Medical Device