BEUDAMED
    23 results · 17ms · Sources: EU EUDAMED, US FDA

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    QMAPP Thermo Dilution CO Y-cable

    Device
    EU MDR · Eu Md Class 1 ·Fysicon B.V.·On the market·1 country

    Willingsford NL

    Manufacturer
    🇳🇱 Netherlands·4 Basic UDI-DIs·4 Devices·Eurofins Electric & Electronics Finland Oy

    2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 26, 2023

    SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 26, 2023

    Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026

    Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026

    Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026

    Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026

    Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026

    Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026

    Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026

    Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026

    Aprobaxil

    Device
    EU MDD · Eu Md Class 2a ·Willingsford NL·On the market·7 countries

    Acapsil

    Device
    EU MDD · Eu Md Class 2a ·Willingsford NL·On the market·7 countries

    Amicapsil-SCI

    Device
    EU MDD · Eu Md Class 2b ·Willingsford NL·On the market·6 countries

    Amicapsil

    Device
    EU MDD · Eu Md Class 2b ·Willingsford NL·On the market·8 countries

    Aprobaxil 750 mg

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Willingsford NL·1 device

    Acapsil 750 mg

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Willingsford NL·1 device

    Amicapsil-SCI

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Willingsford NL·1 device

    Amicapsil 750 mg

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Willingsford NL·1 device