BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    TCM40 Monitoring System,

    Reg #: 3013513377 · FEI: 3013513377 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    4

    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
    K043003

    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
    Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia LPP
    Monitor, Carbon-Dioxide, Cutaneous LKD
    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
    Oximeter DQA

    Proprietary Names

    TCM40 Monitoring System, TCM4 Monitoring System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)