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    ITG ELECTRONICS (MALAYSIA) SDN. BHD.

    FDA registration
    ITG ELECTRONICS (MALAYSIA) SDN. BHD.·1 product·🇲🇾 Malaysia

    Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. Novii Pod - The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Novii Pod also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Novii Pod is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.

    FDA Enforcement
    Class II ·Terminated·MONICA HEALTHCARE LTD·June 21, 2017

    VOCSN

    FDA Adverse Event
    Malfunction ·VENTEC LIFE SYSTEMS, INC·Product code CBK·January 29, 2025

    VOCSN

    FDA Adverse Event
    Malfunction ·VENTEC LIFE SYSTEMS, INC·Product code CBK·September 8, 2022

    VOCSN

    FDA Adverse Event
    Malfunction ·VENTEC LIFE SYSTEMS, INC·Product code CBK·November 18, 2025

    VOCSN

    FDA Adverse Event
    Malfunction ·VENTEC LIFE SYSTEMS, INC·Product code CBK·August 17, 2022

    VOCSN

    FDA Adverse Event
    Malfunction ·VENTEC LIFE SYSTEMS, INC·Product code CBK·January 31, 2025

    VOCSN

    FDA Adverse Event
    Malfunction ·VENTEC LIFE SYSTEMS, INC·Product code CBK·April 9, 2025

    REVIVER

    FDA Adverse Event
    Malfunction ·DEFIBTECH, L.L.C.·Product code MKJ·December 19, 2025

    VOCSN

    FDA Adverse Event
    Malfunction ·VENTEC LIFE SYSTEMS, INC·Product code CBK·April 4, 2025

    HATZALAH

    FDA Adverse Event
    Malfunction ·DEFIBTECH, L.L.C.·Product code MKJ·July 7, 2025

    LIFELINE

    FDA Adverse Event
    Malfunction ·DEFIBTECH, L.L.C.·Product code MKJ·June 27, 2025

    REVIVER

    FDA Adverse Event
    Malfunction ·DEFIBTECH, L.L.C.·Product code MKJ·June 27, 2025

    VOCSN

    FDA Adverse Event
    Malfunction ·VENTEC LIFE SYSTEMS, INC·Product code CBK·November 21, 2025

    REVIVER

    FDA Adverse Event
    Malfunction ·DEFIBTECH, L.L.C.·Product code MKJ·May 21, 2025

    LIFELINE

    FDA Adverse Event
    Malfunction ·DEFIBTECH, L.L.C.·Product code MKJ·June 27, 2025

    LIFELINE

    FDA Adverse Event
    Malfunction ·DEFIBTECH, L.L.C.·Product code MKJ·June 27, 2025

    LD304 MATERNITY BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code HDD·September 19, 2012

    LIFELINE

    FDA Adverse Event
    Malfunction ·DEFIBTECH, L.L.C.·Product code MKJ·April 5, 2024

    LIFELINE

    FDA Adverse Event
    Malfunction ·DEFIBTECH, L.L.C.·Product code MKJ·May 6, 2025