BEUDAMED
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    IMACTIS SAS

    Manufacturer
    🇫🇷 France·3 Basic UDI-DIs·3 Devices

    IMACTIS SAS

    Manufacturer
    🇫🇷 France

    IMACTIS, SAS

    FDA registration
    IMACTIS, SAS·2 products·🇫🇷 France

    Needle Holder (Not sterile)

    Device
    EU MDR · Eu Md Class 1 ·IMACTIS SAS·On the market·13 countries

    Needle Holder

    Device
    EU MDR · Eu Md Class 1 ·IMACTIS SAS·On the market·12 countries

    IMACTIS Navigation station

    Device
    EU MDR · Eu Md Class 2b ·IMACTIS SAS·On the market·15 countries

    IMACTIS CT-Navigation system

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMACTIS non sterile needle holder

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·IMACTIS SAS·1 device

    IMACTIS sterile needle holder

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·IMACTIS SAS·1 device

    IMACTIS® Navigation Station

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·IMACTIS SAS·1 device

    Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)

    FDA Enforcement
    Class II ·Ongoing·Imactis·September 23, 2020

    Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only,

    FDA Enforcement
    Class II ·Ongoing·Imactis·January 29, 2020

    Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100

    FDA Enforcement
    Class II ·Terminated·Imactis·March 24, 2021

    IMACTIS SAS

    System producer
    🇫🇷 France