BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    ABL90 FLEX

    Reg #: 3007490412 · FEI: 3007490412 · Expires 2025
    View on FDA
    Products
    12
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    Radiometer Sp. z o.o
    Registration Number
    3007490412
    FEI Number
    3007490412
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ul. Podmiejska 3
    City
    Stargard Zachodniopomorskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K120197

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

    Proprietary Names

    ABL90 FLEX

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)