BEUDAMED
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    SCANVIEW HER2/NEU FISH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    CEP XY, HER2/neu, UroVysion, ALK

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Applied Spectral Imaging Ltd·1 device

    CE 699509

    Certificate
    MDD Annex II (excluding section 4)·New NI Medical (2011) Ltd.·BSI Group The Netherlands B.V.·1 Basic UDI-DI