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

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    Salvelox Aqua Mix 24

    Device
    EU MDR · Eu Md Class 2a ·Orkla Wound Care AB·On the market·4 countries

    Salvelox Med Blister Rescue Mix 6

    Device
    EU MDR · Eu Md Class 1 ·Orkla Wound Care AB·On the market

    Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through vibration. Within 90 seconds, the immunochemical reaction is completed and the turbidity is measured photometrically at 610 nm. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria.

    FDA Enforcement
    Class III ·Terminated·HemoCue AB·January 9, 2013

    RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·May 26, 2021

    Fixed Lifting Pole

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·ArjoHuntleigh AB·11 devices

    RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·April 1, 2015