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

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    Liquide fixateur Fixall-his RS

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·CARLO ERBA Reagents S.A.S.·1 device

    The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisition workstation. ¿ The gantry contains two orthogonal acquisition units, each of which comprises an X-ray source (high frequency generator + X-ray tube + collimator) and an X-ray detection system (detector + electronics). ¿ The acquisition workstation and its software control the generators and detectors. It is also used to enter patient data, via RIS/HIS or manually, to define acquisition parameters, process images and record images in DICOM 3.0 format. The intended use/indications for use, technological characteristics, and principles of operation of the EOSedge system are described below.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·April 21, 2021

    DIS PAR

    Manufacturer
    🇫🇷 France·1 Basic UDI-DI·1 Device·BUREAU VERITAS ITALIA S.P.A.

    CIS bio international

    Manufacturer
    🇫🇷 France

    NASAL IRRIGATION SOLUTIONS

    Device
    EU MDD · Eu Md Class 2a ·DIS PAR·On the market·1 country

    Isotonic nasal spray

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·DIS PAR·1 device

    IT267632 - 1

    Certificate
    MDD Annex II (excluding section 4)·DIS PAR·BUREAU VERITAS ITALIA S.P.A.·1 Basic UDI-DI

    EBC EUROPE

    Importer
    🇫🇷 France·8 Manufacturers