BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Neumovent Graphnet TS / Critical Care Ventilator

    Reg #: 3011190789 · FEI: 3011190789 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Tecme Corporation
    Registration Number
    3011190789
    FEI Number
    3011190789
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2825 Pacific Drive, Suite B
    City
    Norcross
    State
    GA
    ZIP
    30071
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111595

    Owner / Operator

    Firm Name
    Tecme Corporation
    Operator Number
    10049165
    Address
    2825 Pacific Drive, Suite B
    City
    Norcross
    State
    GA
    Postal Code
    30071
    Country
    US
    Correspondent
    Constanza Demmel

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK

    Proprietary Names

    Neumovent Graphnet TS / Critical Care Ventilator Zonda / Critical Care Ventilator Neumovent GraphNet Advance / Critical Care Ventilator Zonda NEO / Critical Care Ventilator Zonda Plus + /Critical Care Ventilator Neumovent GraphNet NEO / Critical Care Ventilator

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)