BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    TNI softFlow 50 Hospital System 10-50L

    Reg #: 3018900343 · FEI: 3018900343 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Mechatronic GmbH
    Registration Number
    3018900343
    FEI Number
    3018900343
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Am Gewerbepark 2
    City
    Hoehn Rhineland-Palatinate
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K180474

    Owner / Operator

    Firm Name
    TNI medical AG
    Operator Number
    10051448
    Address
    52 Discovery
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Mathew Jimenez

    US Agent

    Business Name
    Masimo Corporation
    Contact Name
    Mathew Jimenez
    Address
    52 Discovery
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 2977558

    Products

    Device Name Product Code
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT

    Proprietary Names

    TNI softFlow 50 Hospital System 10-50L

    Establishment Types

    Manufacture Medical Device