BEUDAMED
    5 results · 20ms · Sources: EU EUDAMED, US FDA

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    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).

    FDA Enforcement
    Class II ·Ongoing·SenTec AG·September 27, 2023

    SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Sentec AG·November 28, 2012

    HCI Solutions AG

    Manufacturer
    🇨🇭 Switzerland·1 Basic UDI-DI·1 Device

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDR · Eu Md Class 2a ·HCI Solutions AG·Not intended for eu market

    Documedis CDS.CE

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·HCI Solutions AG·1 device