BEUDAMED
    20 results · 19ms · Sources: EU EUDAMED, US FDA

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    The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·September 28, 2022

    Cosmo Technologies

    Manufacturer
    🇮🇪 Ireland·1 Basic UDI-DI·1 Device·ISTITUTO SUPERIORE DI SANITA'

    Mirai Medical Limited

    Manufacturer
    🇮🇪 Ireland·5 Basic UDI-DIs·5 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

    Eleview

    Device
    EU MDD · Eu Md Class 2a ·Cosmo Technologies·On the market·17 countries

    Abbott Rapid Dx International Limited

    Authorized representative
    🇮🇪 Ireland·5 Manufacturers·4 Devices

    EPORE Generator

    Device
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·On the market·7 countries

    EPORE Generator

    Device
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·On the market·7 countries

    EPORE Generator

    Device
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·On the market·7 countries

    CUTIS

    Device
    EU MDD · Eu Md Class 2b ·Mirai Medical Limited·On the market·7 countries

    EndoVE

    Device
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·On the market·7 countries

    Abbott Rapid Dx International Limited

    Importer
    🇮🇪 Ireland·11 Manufacturers

    Eleview

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Cosmo Technologies·1 device

    Med-Di-Dia Limited

    Authorized representative
    🇮🇪 Ireland·2 Manufacturers·1 Device

    ePORE Generator

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·1 device

    EPORE Generator

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·1 device

    EPORE Generator

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·1 device

    EndoVE

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·1 device

    CUTIS

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Mirai Medical Limited·1 device

    QPZ-1956-21

    Certificate
    MDD Annex V·Cosmo Technologies·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI

    2027/MDD

    Certificate
    MDD Annex II (excluding section 4)·Mirai Medical Limited·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·5 Basic UDI-DIs