BEUDAMED
    FDA Registration Active 🇨🇳 China

    A15445 IMMAGE 800

    Reg #: 3027977508 · FEI: 3027977508 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
    Registration Number
    3027977508
    FEI Number
    3027977508
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.11, Zhensheng Road, Suzhou Industrial Park, Area 1, 1st Floor, Building 4; Area 1, Building 3; Area 1, Building 2
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K962294

    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 G 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
    Nephelometer, For Clinical Use JQX

    Proprietary Names

    A15445 IMMAGE 800

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)