BEUDAMED
    26 results · 23ms · Sources: EU EUDAMED, US FDA

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    CR-03-1087-817-23

    Certificate
    MDR QMS·Nexstim Plc·Eurofins Electric & Electronics Finland Oy

    EUFI29-21000160-S

    Certificate
    MDD Annex II (excluding section 4)·Nexstim Plc·Eurofins Electric & Electronics Finland Oy·3 Basic UDI-DIs

    EPS Vascular Oy

    Importer
    🇫🇮 Finland·3 Manufacturers

    Telespro Finland Oy

    Importer
    🇫🇮 Finland·1 Manufacturer

    A Class Beauty and Design Oy

    Importer
    🇫🇮 Finland·1 Manufacturer

    Teoteam Oy

    Importer
    🇫🇮 Finland·1 Manufacturer

    Oy Implantona Finland Ltd.

    Importer
    🇫🇮 Finland·2 Manufacturers

    Arthrone Oy

    Importer
    🇫🇮 Finland·7 Manufacturers

    Pamark Business Oy

    Importer
    🇫🇮 Finland·32 Manufacturers

    Planmeca Oy

    Importer
    🇫🇮 Finland·8 Manufacturers

    Ossano Scandinavia Oy Ab

    Importer
    🇫🇮 Finland·3 Manufacturers

    NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Enforcement
    Class II ·Ongoing·Nexstim PLC·June 14, 2017

    Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Enforcement
    Class II ·Ongoing·Nexstim PLC·June 14, 2017

    Sharkmed Oy

    Importer
    🇫🇮 Finland·18 Manufacturers

    Melon Oy

    Importer
    🇫🇮 Finland·5 Manufacturers

    Mills Enterprises LTD Oy

    Importer
    🇫🇮 Finland·6 Manufacturers

    Mekalasi Oy

    Importer
    🇫🇮 Finland·10 Manufacturers

    Cardirad Oy

    Importer
    🇫🇮 Finland·7 Manufacturers

    Elers Medical Finland Oy

    Importer
    🇫🇮 Finland·6 Manufacturers

    Steripolar Oy

    Importer
    🇫🇮 Finland·18 Manufacturers