BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Monsoon Critical Care Jet Ventilator

    Reg #: 3016450067 · FEI: 3016450067 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Thora Tech GmbH
    Registration Number
    3016450067
    FEI Number
    3016450067
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gutfleischstr. 3-5
    City
    Giesen Lower Saxony
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K012691

    Owner / Operator

    Firm Name
    Thora Tech GmbH
    Operator Number
    10087914
    Address
    Gutfleischstr. 3-5
    City
    Giessen
    State
    Hesse
    Postal Code
    35390
    Country
    DE
    Correspondent
    Fatih Yueksel

    US Agent

    Business Name
    Imagenix, Inc.
    Contact Name
    Stephen Gorski
    Address
    S65W35739 Piper Road
    City
    Eagle
    State
    WI
    ZIP
    53119
    Country
    US
    Email
    [email protected]
    Phone
    414 7374596

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT

    Proprietary Names

    Monsoon Critical Care Jet Ventilator LaserJet Catheter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device