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

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    OKO SOLUTION

    Importer
    🇫🇷 France·11 Manufacturers

    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

    BORA

    Device
    EU MDR · Eu Md Class 1 ·ALTER ECO SANTE Sarl·On the market

    Bora Connect

    Device
    EU MDR · Eu Md Class 2a ·BiOSENCY·On the market·5 countries

    Bora Band

    Device
    EU MDR · Eu Md Class 2a ·BiOSENCY·On the market·5 countries

    actiTENS belt/ bra accessory

    Device
    EU MDR · Eu Md Class 1 ·SUBLIMED·On the market·1 country

    Tabouret de douche Bora gris

    Device
    EU MDR · Eu Md Class 1 ·IDENTITES 49·On the market

    Tabouret de douche Bora blanc

    Device
    EU MDR · Eu Md Class 1 ·IDENTITES 49·On the market

    Chaise de douche Bora grise

    Device
    EU MDR · Eu Md Class 1 ·IDENTITES 49·On the market

    Chaise de douche Bora blanche

    Device
    EU MDR · Eu Md Class 1 ·IDENTITES 49·On the market

    Tabouret de douche Bora pliant gris

    Device
    EU MDR · Eu Md Class 1 ·IDENTITES 49·On the market

    Tabouret de douche Bora pliant blanc

    Device
    EU MDR · Eu Md Class 1 ·IDENTITES 49·On the market

    ANNIE BAUER CONFORT

    Authorized representative
    🇫🇷 France·1 Manufacturer·599 Devices

    ANNIE BAUER CONFORT

    Importer
    🇫🇷 France·2 Manufacturers

    Remedee wristband OA

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Remedee Labs SA·2 devices