BEUDAMED
    13 results · 9ms · Sources: EU EUDAMED, US FDA

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    Eyenuk, Inc.

    Manufacturer
    🇺🇸 United States·1 Basic UDI-DI·1 Device·Intertek Medical Notified Body AB and INTERTEK SEMKO AB

    NorthEast Monitoring, Inc.

    Manufacturer
    🇺🇸 United States·6 Basic UDI-DIs·13 Devices·INTERTEK SEMKO AB

    Analysis Software

    Device
    EU MDD · Eu Md Class 2a ·NorthEast Monitoring, Inc.·On the market·12 countries

    DR400

    Device
    EU MDD · Eu Md Class 2a ·NorthEast Monitoring, Inc.·On the market·13 countries

    DR200

    Device
    EU MDD · Eu Md Class 2a ·NorthEast Monitoring, Inc.·On the market·13 countries

    EyeArt

    Device
    EU MDD · Eu Md Class 2a ·Eyenuk, Inc.·On the market·1 country

    NorthEast DR400 Holter Recorder

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·NorthEast Monitoring, Inc.·1 device

    NorthEast DR200 Holter Recorder

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·NorthEast Monitoring, Inc.·1 device

    Analysis Software

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·NorthEast Monitoring, Inc.·1 device

    EyeArt

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Eyenuk, Inc.·1 device

    41314934-05

    Certificate
    MDD Annex II (excluding section 4)·NorthEast Monitoring, Inc.·INTERTEK SEMKO AB·3 Basic UDI-DIs

    41302127-00

    Certificate
    MDD Annex II (excluding section 4)·Eyenuk, Inc.·INTERTEK SEMKO AB·1 Basic UDI-DI

    28620136171

    Certificate
    MDR QMS·Eyenuk, Inc.·Intertek Medical Notified Body AB