BEUDAMED
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    Hamamatsu Photonics K.K., Systems Division

    Manufacturer
    🇯🇵 Japan·5 Basic UDI-DIs·5 Devices·4 Importers

    Hamamatsu Photonics K.K., Solid State Division

    Manufacturer
    🇯🇵 Japan·1 Basic UDI-DI·2 Devices·1 Importer

    NanoZoomer S360MD Slide scanner system

    FDA UDI
    HAMAMATSU PHOTONICS K.K.·04582389010659·

    pde-neoII

    FDA UDI
    HAMAMATSU PHOTONICS K.K.·04582389010543·

    PDE

    FDA UDI
    HAMAMATSU PHOTONICS K.K.·04582389010031·

    PDE-GEN3

    FDA UDI
    HAMAMATSU PHOTONICS K.K.·04582389010871·

    pde-neo

    FDA UDI
    HAMAMATSU PHOTONICS K.K.·04582389010093·

    NIRO-200NX

    FDA UDI
    HAMAMATSU PHOTONICS K.K.·04582389010062·

    HAMAMATSU PHOTONICS K.K., SYSTEMS DIVISION

    FDA registration
    HAMAMATSU PHOTONICS K.K., SYSTEMS DIVISION·5 products·🇯🇵 Japan

    PDE-GEN3

    Device
    EU MDR · Eu Md Class 1 ·Hamamatsu Photonics K.K., Systems Division·On the market·28 countries

    NanoZoomer S540MD Slide scanner system

    Device
    EU IVDR · Eu Ivd Class A ·Hamamatsu Photonics K.K., Systems Division·On the market·32 countries

    NanoZoomer S20MD Slide scanner system

    Device
    EU IVDR · Eu Ivd Class A ·Hamamatsu Photonics K.K., Systems Division·On the market·32 countries

    NanoZoomer S360MD Slide scanner system

    Device
    EU IVDR · Eu Ivd Class A ·Hamamatsu Photonics K.K., Systems Division·On the market·32 countries

    NanoZoomer S60v2MD Slide scanner system

    Device
    EU IVDR · Eu Ivd Class A ·Hamamatsu Photonics K.K., Systems Division·On the market·32 countries

    SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY

    Device
    EU MDR · Eu Md Class 2a ·Hamamatsu Photonics K.K., Solid State Division·Not intended for eu market

    SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY

    Device
    EU MDR · Eu Md Class 2a ·Hamamatsu Photonics K.K., Solid State Division·Not intended for eu market

    NANOZOOMER S360 (THIS IS AN IVDD PRODUCT, NOT SOLD IN THE U.S.)

    FDA Adverse Event
    Malfunction ·HAMAMATSU PHOTONICS K.K, SYSTEMS DIVISION,·Product code PSY·June 5, 2023

    NanoZoomer S540MD Slide scanner system

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Hamamatsu Photonics K.K., Systems Division·1 device

    PDE-GEN3

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Hamamatsu Photonics K.K., Systems Division·1 device

    NanoZoomer S20MD Slide scanner system

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Hamamatsu Photonics K.K., Systems Division·1 device