BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Rapidlab 348

    Reg #: 9610633 · FEI: 3002806693 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD
    Registration Number
    9610633
    FEI Number
    3002806693
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NORTHERN RD., CHILTON INDUSTRIAL ESTATE
    City
    SUDBURY Suffolk
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K962021

    Owner / Operator

    Firm Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Operator Number
    9096044
    Address
    Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
    City
    Tarrytown
    State
    NY
    Postal Code
    10591
    Country
    US

    US Agent

    Business Name
    Siemens Healthcare Diagnostics Inc.
    Contact Name
    Felix Akinrinola
    Address
    Point Of Care Headquarters, 333 Coney Street
    City
    East Walpole
    State
    MA
    ZIP
    02032
    Country
    US
    Email
    [email protected]
    Phone
    781 8561738

    Products

    Device Name Product Code
    Electrode, Ion Specific, Calcium JFP
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Potassium CEM
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Instrument, Hematocrit, Automated GKF
    Electrode, Ion Specific, Sodium JGS

    Proprietary Names

    Rapidlab 348 Blood Gas Systems Family

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device