BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    ABL90 FLEX PLUS

    Reg #: 3013513377 · FEI: 3013513377 · Expires 2025
    View on FDA
    Products
    13
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    13

    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
    K160153

    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
    Assay, Fetal Hemoglobin KQI
    Calibrator, Multi-Analyte Mixture JIX
    Assay, Carboxyhemoglobin GHS
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Acid, Lactic, Enzymatic Method KHP
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    Glucose Oxidase, Glucose CGA
    Electrode, Ion Specific, Potassium CEM
    System, Hemoglobin, Automated GKR
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Calcium JFP
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Electrode, Ion Specific, Sodium JGS

    Proprietary Names

    ABL90 FLEX PLUS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198