BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    IFA: Granulocyte Mosaic 13 EUROPattern

    Reg #: 3007361513 · FEI: 3007361513 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    EUROIMMUN Medizinische Labordiagnostika AG
    Registration Number
    3007361513
    FEI Number
    3007361513
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    EUROIMMUN AG, Werkstrasse 1
    City
    Dassow Mecklenburg-Western Pomerania
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K172582

    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
    Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) MVJ
    Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use PIV
    Test System, Antineutrophil Cytoplasmic Antibodies (Anca) MOB

    Proprietary Names

    IFA: Granulocyte Mosaic 13 EUROPattern EUROPLUS Granulocyte Mosaic 22 EUROPattern EUROPLUS Granulocyte Mosaic 25 EUROPattern EUROPLUS Granulocyte Mosaic 32 EUROPattern IFA: Granulocyte Mosaic 2 EUROPattern EUROPattern Classifier

    Establishment Types

    Manufacture Medical Device