BEUDAMED
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    GTI MEDICAL LTD

    FDA registration
    GTI MEDICAL LTD·1 product·🇮🇱 Israel

    S-Path Pre-loaded RX Biliary Stent System (80mm)

    FDA UDI
    ENDO GI MEDICAL LTD·00860005738229·The EndoGI S-Path Pre-loaded RX Biliary Stent S...

    X-Path Pre-loaded RX-OTW Double Biliary Stents System

    FDA UDI
    ENDO GI MEDICAL LTD·00860005738205·The EndoGI X-Path Pre-loaded RX-OTW Double Bili...

    S-Path Pre-loaded RX Biliary Stent System

    FDA UDI
    ENDO GI MEDICAL LTD·00860005738212·The EndoGI S-Path Pre-loaded RX Biliary Stent S...

    EndoGI Specialized S-Path Delivery System

    FDA UDI
    ENDO GI MEDICAL LTD·00860005738250·The EndoGI Specialized S-Path Biliary Delivery ...

    EndoGI Specialized S-Path Delivery System

    FDA UDI
    ENDO GI MEDICAL LTD·00860005738243·The EndoGI Specialized S-Path Biliary Delivery ...

    S-Path Biliary Stent System (140mm)

    FDA UDI
    ENDO GI MEDICAL LTD·00860005738236·The EndoGI S-Path Pre-loaded RX Biliary Stent S...

    Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G

    FDA Enforcement
    Class II ·Ongoing·Ellex Medical Pty Ltd.·July 5, 2023

    Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).

    FDA Enforcement
    Class II ·Ongoing·SEER MEDICAL PTY LTD·September 25, 2024

    Fairmont Medical Products Pty Ltd

    System producer
    🇦🇺 Australia

    GRI-Alleset Limited B.V.

    Importer
    🇳🇱 Netherlands·1 Manufacturer

    G2S 056820 0038

    Certificate
    MDD Annex V·GRI Medical & Electronic Technology Co., Ltd.·TÜV SÜD Product Service GmbH·91 Basic UDI-DIs

    G2 056820 0037

    Certificate
    MDD Annex V·GRI Medical & Electronic Technology Co., Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

    Elers Medical Finland Oy

    Importer
    🇫🇮 Finland·6 Manufacturers

    Sharkmed Oy

    Importer
    🇫🇮 Finland·18 Manufacturers

    MedPath GmbH

    Authorized representative
    🇩🇪 Germany·537 Manufacturers·13464 Devices

    Lotus NL B.V.

    Authorized representative
    🇳🇱 Netherlands·584 Manufacturers·21427 Devices

    Lohmann & Rauscher International GmbH & Co. KG

    Importer
    🇩🇪 Germany·23 Manufacturers

    Obelis s.a.

    Authorized representative
    🇧🇪 Belgium·546 Manufacturers·18515 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices