BEUDAMED
    6 results · 18ms · Sources: EU EUDAMED, US FDA

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    GO-Pen ApS

    Manufacturer
    🇩🇰 Denmark

    Malaria Pan/Pf Antigen Test (Colloidal Gold)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

    Malaria Pan/Pf Antigen Test (Colloidal Gold)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

    Malaria Pan/Pf Antigen Test (Colloidal Gold)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

    Malaria Pan/Pf Antigen Test (Colloidal Gold)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

    BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

    FDA Enforcement
    Class II ·Terminated·B-K Medical A/S·August 10, 2016