BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Beckman Coulter Biomedical GmbH

    Reg #: 3006677029 · FEI: 3006677029 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    Beckman Coulter Biomedical GmbH
    Registration Number
    3006677029
    FEI Number
    3006677029
    Status
    Active
    Expiry Year
    2026
    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

    US Agent

    Business Name
    Beckman Coulter, Inc.
    Contact Name
    Ian Pilcher
    Address
    1000 Lake Hazeltine Dr
    City
    Chaska
    State
    MN
    ZIP
    55318
    Country
    US
    Email
    [email protected]
    Phone
    443 3506459

    Products

    Device Name Product Code
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Ferritin, Antigen, Antiserum, Control DBF
    Acid, Folic, Radioimmunoassay CGN
    Radioassay, Vitamin B12 CDD
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Calculator/Data Processing Module, For Clinical Use JQP

    Proprietary Names

    DxA 5000 DxA 5000 Fit ODL25255 AutoMate 2550 LAB INSTRUMENT ODL25120 AutoMate 1200 LAB INSTRUMENT ODL25125 AutoMate 1250 LAB INSTRUMENT ODL25250 AutoMate 2500 LAB INSTRUMENT B36352 Power Express Sample Processing System B90918 Power Express Sample Processing System PLC AutoMate 2500 Sample Processing System AutoMate 1200 Sample Processing System AutoMate 2550 Sample Processing System AutoMate 1250 Sample Processing System A18894 Automate 800 Sample Processing System A18896 Automate 600 Sample Processing System Command Central Kaluza C Perpetual License (PN C10574) Kaluza C Flow Cytometry Software (PN C21166) Kaluza C Single Use 1 Year License (PN C10575) Kaluza C 10 User Network (PN C10576) DxOne Workflow Manager Kaluza C 5 User Network (PN C10577) REMISOL ADVANCE A11036 Power Processor Sample Processing System Power Processor PowerCel B05033 Power Link

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility