BEUDAMED
    211 results · 110ms · Sources: EU EUDAMED, US FDA

    ClearPoint Array System

    FDA 510(k)
    FDA Class 2 ·Neurology

    ClearPoint System (Software Version 2.2)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ClearPoint Array System (version 1.1)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ClearPoint Array System (Version 1.2)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Bone Anchor (NGS-BA-01)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ClearPoint Maestro Brain Model

    FDA 510(k)
    FDA Class 2 ·Radiology

    SmartTwist MR Hand Drill

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·ClearPoint Neuro, Inc.·1 device

    SmartFrame XG Targeting Cannula

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

    ClearPoint Inflexion SMS Avanto HFF

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·ClearPoint Neuro, Inc.·1 device

    3803643CE01

    Certificate
    MDD Annex II (excluding section 4)·ClearPoint Neuro, Inc.·DEKRA Certification B.V.·1 Basic UDI-DI

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices