BEUDAMED
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    OrthoXel DAC

    Manufacturer
    🇮🇪 Ireland·776 Basic UDI-DIs·786 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    AventaMed DAC

    Manufacturer
    🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V.

    Mainstay Medical Limited

    Manufacturer
    🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V.

    BES Healthcare Ireland Ltd

    Importer
    🇮🇪 Ireland

    Medical Device Management Ltd

    Authorized representative
    🇮🇪 Ireland·27 Manufacturers·1124 Devices

    Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·May 15, 2024

    CS Life Sciences Europe Ltd

    Authorized representative
    🇮🇪 Ireland·35 Manufacturers·444 Devices

    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

    This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·September 18, 2019

    Apex Antegrade Femoral Endcap 15mm length

    Device
    EU MDD · Eu Md Class 2b ·OrthoXel DAC·On the market·1 country

    Apex Antegrade Femoral Endcap 10mm Length

    Device
    EU MDD · Eu Md Class 2b ·OrthoXel DAC·On the market·1 country

    Apex Antegrade Femoral Endcap 5mm Length

    Device
    EU MDD · Eu Md Class 2b ·OrthoXel DAC·On the market·1 country

    Apex Antegrade Femoral Endcap 0mm Length

    Device
    EU MDD · Eu Md Class 2b ·OrthoXel DAC·On the market·1 country

    Apex Femoral Nail PF Right Ø 10.0 x 460mm

    Device
    EU MDD · Eu Md Class 2b ·OrthoXel DAC·On the market·1 country

    Apex Femoral Nail PF Right Ø 10.0 x 440mm

    Device
    EU MDD · Eu Md Class 2b ·OrthoXel DAC·On the market·1 country

    Apex Femoral Nail PF Right Ø 10.0 x 420mm

    Device
    EU MDD · Eu Md Class 2b ·OrthoXel DAC·On the market·1 country

    Apex Femoral Nail PF Right Ø 10.0 x 400mm

    Device
    EU MDD · Eu Md Class 2b ·OrthoXel DAC·On the market·1 country

    Apex Femoral Nail PF Right Ø 10.0 x 380mm

    Device
    EU MDD · Eu Md Class 2b ·OrthoXel DAC·On the market·1 country

    Apex Femoral Nail PF Right Ø 10.0 x 360mm

    Device
    EU MDD · Eu Md Class 2b ·OrthoXel DAC·On the market·1 country

    Apex Femoral Nail PF Right Ø 10.0 x 340mm

    Device
    EU MDD · Eu Md Class 2b ·OrthoXel DAC·On the market·1 country