BEUDAMED
    18 results · 27ms · Sources: EU EUDAMED, US FDA

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    Hemabox - POC-W102 - Windows10E LSTB 2016

    Device
    EU MDR · Eu Md Class 1 ·Engenering Medical Application - EMA·On the market·2 countries

    HEMABOX-POC-W102 - Windows7Embedded

    Device
    EU MDR · Eu Md Class 1 ·Engenering Medical Application - EMA·On the market·2 countries

    GAMIDA TECH

    Manufacturer
    🇫🇷 France·4 Basic UDI-DIs·4 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

    Hemabox

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Engenering Medical Application - EMA·2 devices

    MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA INSTRUMENTS - CONSUMABLES

    Device
    EU MDD · Eu Md Class 2b ·GAMIDA TECH·No longer on the market·10 countries

    MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA INSTRUMENTS - CONSUMABLES

    Device
    EU MDD · Eu Md Class 2b ·GAMIDA TECH·On the market·11 countries

    MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT

    Device
    EU MDD · Eu Md Class 2b ·GAMIDA TECH·On the market·8 countries

    Med-Imaps SASU

    Authorized representative
    🇫🇷 France·1 Manufacturer·3 Devices

    MDR-0021

    Certificate
    MDR QMS·Delmont imaging·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

    steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·January 1, 2014

    ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·July 5, 2017

    EOS System X- ray beam Digital radiography system used in general radiographic examinations.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·January 15, 2014

    sterEOS workstation

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·September 26, 2018

    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

    Set SunChip1 ouvert

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·GAMIDA TECH·1 device

    Set SunChip 2

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·GAMIDA TECH·1 device

    SunChip2

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·GAMIDA TECH·1 device

    1850/MDD

    Certificate
    MDD Annex II (excluding section 4)·GAMIDA TECH·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·3 Basic UDI-DIs