BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    Radiometer Sp. z o.o

    Reg #: 3007490412 · FEI: 3007490412 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    22

    Registration Details

    Registration Name
    Radiometer Sp. z o.o
    Registration Number
    3007490412
    FEI Number
    3007490412
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ul. Podmiejska 3
    City
    Stargard Zachodniopomorskie
    Country
    PL

    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, Sodium JGS
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Calcium JFP
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Syringe, Antistick MEG
    Glucose Oxidase, Glucose CGA
    Assay, Fetal Hemoglobin KQI
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Calibrator, Multi-Analyte Mixture JIX
    Acid, Lactic, Enzymatic Method KHP
    Assay, Carboxyhemoglobin GHS
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    Electrode, Ion Specific, Potassium CEM
    System, Hemoglobin, Automated GKR
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Electrode, Ion Based, Enzymatic, Creatinine CGL
    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
    Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia LPP
    Oximeter DQA
    Oximeter, Ear DPZ
    Monitor, Carbon-Dioxide, Cutaneous LKD
    Tube, Collection, Capillary Blood GIO

    Proprietary Names

    ABL90 FLEX PLUS ABL800 Flex Series ABL837 FLEX safeCLINITUBES TCM TOSCA Monitoring System TCM CombiM Monitoring System ABL90 FLEX TCM400 Monitoring System TCM4 Monitoring System TCM40 Monitoring System,

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)