BEUDAMED
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    Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and HF s)

    FDA Enforcement
    Class II ·Ongoing·Agfa Healthcare NV·October 16, 2024

    BlueDot ANA + DFS-70 IgG

    Device
    EU IVDD · Eu Ivd General ·D-tek s.a.·On the market·18 countries

    BlueDiver Dot ANA + DFS-70 IgG

    Device
    EU IVDD · Eu Ivd General ·D-tek s.a.·On the market·18 countries

    BlueDot ANA + DFS-70 IgG

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·D-tek s.a.·1 device