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.

    Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·August 30, 2023

    Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·November 13, 2019

    Nuevo International Bio Security Limited

    Importer
    🇮🇪 Ireland

    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

    Apex Femoral Nail PF Right Ø 10.0 x 320mm

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

    Apex Femoral Nail PF Right Ø 10.0 x 300mm

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

    Apex Femoral Nail PF Right Ø 10.0 x 280mm

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