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    Shanghai Pulse Medical Technology, Inc.

    Manufacturer
    🇨🇳 China·8 Basic UDI-DIs·8 Devices·2 Importers·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    PULSE TECHNOLOGIES, INC.

    FDA registration
    PULSE TECHNOLOGIES, INC.·19 products·🇺🇸 United States

    AngioPlus Core

    Device
    EU MDD · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·On the market·1 country

    μFR

    Device
    EU MDR · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·On the market·12 countries

    CT-μFR

    Device
    EU MDD · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·On the market·1 country

    UFR

    Device
    EU MDD · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·On the market·1 country

    OFR

    Device
    EU MDD · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·On the market·1 country

    OctPlus

    Device
    EU MDR · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·On the market·1 country

    UFR

    Device
    EU MDR · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·On the market·1 country

    CT-μFR

    Device
    EU MDR · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·On the market·6 countries

    P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.

    FDA Enforcement
    Class II ·Terminated·SonoSite, Inc.·October 23, 2013

    SIEMENS SENSIS

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MHX·July 21, 2005

    IvusPlus

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·1 device

    OctPlus

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·1 device

    CtaPlus

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·1 device

    OCT-Derived Fractional Flow Reserve Analysis Software

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·1 device

    IVUS-Derived Fractional Flow Reserve Analysis Software

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·1 device

    CCTA-Derived Fractional Flow Reserve Analysis Software

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·1 device

    Quantitative Flow Ratio Analysis Software

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·1 device

    AngioPlus Core

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Shanghai Pulse Medical Technology, Inc.·1 device