BEUDAMED
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    MYCOLOGY NA REAGENTS - OTHER

    Device
    EU IVDD · Eu Ivd General ·TECOmedical AG·On the market

    V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).

    FDA Enforcement
    Class II ·Ongoing·SenTec AG·June 28, 2023

    Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    Airex AG

    Manufacturer
    🇨🇭 Switzerland·2 Basic UDI-DIs·75 Devices·8 Importers

    Ares Trading SA

    Manufacturer
    🇨🇭 Switzerland·6 Basic UDI-DIs·47 Devices

    Acticore AG

    Manufacturer
    🇨🇭 Switzerland

    Kieser Training AG

    Manufacturer
    🇨🇭 Switzerland

    Balance-pad Cloud Olive

    Device
    EU MDR · Eu Md Class 1 ·Airex AG·On the market·28 countries

    Heritage 190 Olive

    Device
    EU MDR · Eu Md Class 1 ·Airex AG·On the market·18 countries

    Heritage 190 Olive Eyelets

    Device
    EU MDR · Eu Md Class 1 ·Airex AG·On the market·8 countries

    Fitline 140 Water blue Eyelets

    Device
    EU MDR · Eu Md Class 1 ·Airex AG·On the market·9 countries

    Fitline Studio Slate Eyelets

    Device
    EU MDR · Eu Md Class 1 ·Airex AG·On the market·9 countries

    Fitline 180 Pink Eyelets

    Device
    EU MDR · Eu Md Class 1 ·Airex AG·On the market·9 countries

    Fitline 140 Pink Eyelets

    Device
    EU MDR · Eu Md Class 1 ·Airex AG·On the market·8 countries

    Balance-beam Lava

    Device
    EU MDR · Eu Md Class 1 ·Airex AG·On the market·32 countries

    Balance-pad Lava

    Device
    EU MDR · Eu Md Class 1 ·Airex AG·On the market·32 countries

    Coronella 185 Slate Eyelets

    Device
    EU MDR · Eu Md Class 1 ·Airex AG·On the market·9 countries

    Pilates 190 Anthracite Eyelets

    Device
    EU MDR · Eu Md Class 1 ·Airex AG·On the market·9 countries