BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DxA 5000 Fit

    Reg #: 3006677029 · FEI: 3006677029 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Beckman Coulter Biomedical GmbH
    Registration Number
    3006677029
    FEI Number
    3006677029
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Sauerbruchstr. 50
    City
    Munchen Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K190298

    Owner / Operator

    Firm Name
    BECKMAN COULTER, INC.
    Operator Number
    2050012
    Address
    250 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US
    Correspondent
    David G Davis

    US Agent

    Business Name
    Beckman Coulter, Inc.
    Contact Name
    David Davis
    Address
    250 S. Kraemer Blvd
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US
    Email
    [email protected]
    Phone
    469 2368180

    Products

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

    Proprietary Names

    DxA 5000 Fit DxA 5000 ODL25255 AutoMate 2550 LAB INSTRUMENT ODL25125 AutoMate 1250 LAB INSTRUMENT ODL25120 AutoMate 1200 LAB INSTRUMENT ODL25250 AutoMate 2500 LAB INSTRUMENT

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility