BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Phadia 2500E, Phadia 2500EE, Phadia 5000E, and Phadia 5000E+E

    Reg #: 9680745 · FEI: 3005774014 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PHADIA GMBH
    Registration Number
    9680745
    FEI Number
    3005774014
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MUNZINGER STRASSE 7
    City
    FREIBURG Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K190710

    Owner / Operator

    Firm Name
    PHADIA AB
    Operator Number
    9004441
    Address
    Rapsgatan 7P, P.O. Box 6460
    City
    UPPSALA
    State
    SE-C
    Postal Code
    75137
    Country
    SE

    US Agent

    Business Name
    Phadia US Inc.
    Contact Name
    Carla Krause
    Address
    4169 Commercial Avenue
    City
    Portage
    State
    MI
    ZIP
    49002
    Country
    US
    Email
    [email protected]
    Phone
    616 2864138

    Products

    Device Name Product Code
    Extractable Antinuclear Antibody, Antigen And Control LLL

    Proprietary Names

    Phadia 2500E, Phadia 2500EE, Phadia 5000E, and Phadia 5000E+E EliA SymphonyS

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)