BEUDAMED
    10 results · 24ms · Sources: EU EUDAMED, US FDA

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    Non Sterile Non Woven Euroswabs

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·GS Medical·7 devices

    Non-woven swab

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Fleming Medical ·3 devices

    Non Sterile Euroswabs

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·GS Medical·1 device

    Non Sterile Absorbent Pads

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·GS Medical·3 devices

    Masterplast Non Adherent Dressing Pad

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·151 Products (Ireland)·1 device

    Non Sterile Gamgee Pieces (pre-cut)

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·GS Medical·2 devices

    Sterile non-woven balls 35mm (20x20)

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·GS Medical·10 devices

    NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·July 28, 2021

    Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon¿ clinical sample concentrators are for in vitro diagnostic use and are intended for concentrating serum, urine, cerebrospinal fluid, and other body fluids prior to analysis.

    FDA Enforcement
    Class II ·Terminated·Merck Millipore Ltd.·November 28, 2018

    The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Ireland, Inc.·January 28, 2026