BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    944-130 S4980 Rinse Solution

    Reg #: 3013513377 · FEI: 3013513377 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    Radiometer Solutions Sp. z o.o.
    Registration Number
    3013513377
    FEI Number
    3013513377
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Stalowa 6
    City
    Stargard Zachodniopomorskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K041874

    Owner / Operator

    Firm Name
    RADIOMETER MEDICAL APS
    Operator Number
    8020503
    Address
    AAKANDEVEJ 21, --
    City
    BROENSHOEJ
    State
    Hovedstaden
    Postal Code
    2700
    Country
    DK
    Correspondent
    Hsiao-Qing Chow

    US Agent

    Business Name
    RADIOMETER AMERICA, INC.
    Contact Name
    MATT ACKERMAN
    Address
    250 S Kraemer Blvd
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US
    Email
    [email protected]
    Phone
    657 2861022

    Products

    Device Name Product Code
    Electrode, Ion Specific, Potassium CEM
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Calcium JFP
    Acid, Lactic, Enzymatic Method KHP
    Assay, Fetal Hemoglobin KQI
    Assay, Carboxyhemoglobin GHS
    Diazo Colorimetry, Bilirubin CIG
    Electrode, Ion Specific, Sodium JGS
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Glucose Oxidase, Glucose CGA

    Proprietary Names

    944-130 S4980 Rinse Solution 905-802 D513 Disposable Waste Container 944-127 S1820 Calibration Solution 1 944-136 S8377 Cleaning Solution Met II Solution 944-155 Rinse Solution II S4987 600mL

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)