BEUDAMED
    52 results · 119ms · Sources: EU EUDAMED, US FDA

    AUTO DETECT FOR TELAHEART DR200/E-A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DR180+OXY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOLTER LX ANALYSIS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DR300 HOLTER MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DR200 patient cable

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·NorthEast Monitoring, Inc.·6 devices

    DR400 patient cable

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·NorthEast Monitoring, Inc.·2 devices

    NEMEL electrode patch used with the DR400

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·NorthEast Monitoring, Inc.·2 devices

    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

    41314934-05

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

    MediMark Europe Sarl.

    Authorized representative
    🇫🇷 France·35 Manufacturers·3394 Devices