BEUDAMED
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    Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration). Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required).

    FDA Enforcement
    Class II ·Terminated·Fresenius Vial Sa·November 7, 2018

    Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons.

    FDA Enforcement
    Class I ·Terminated·MEDTECH SAS·November 13, 2019

    ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

    FDA Enforcement
    Class II ·Terminated·MEDTECH SAS·June 13, 2018

    Blue DNA Companion

    Importer
    🇫🇷 France

    Ziwig

    Importer
    🇫🇷 France·1 Manufacturer

    CEMO

    Importer
    🇫🇷 France·1 Manufacturer

    ANNIE BAUER CONFORT

    Importer
    🇫🇷 France·2 Manufacturers

    ANNIE BAUER CONFORT

    Authorized representative
    🇫🇷 France·1 Manufacturer·599 Devices

    Remedee wristband OA

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