BEUDAMED
    5 results · 21ms · Sources: EU EUDAMED, US FDA

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    CA CAL S

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·SYSMEX CORPORATION·2 devices

    XN CAL

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·SYSMEX CORPORATION·1 device

    XN CAL PF

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·SYSMEX CORPORATION·1 device

    CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·March 18, 2026

    DxC 700 AU, REF: B86444, B86446

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·March 18, 2026