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    Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-00 Firmware versions: COBASa_2.2.0, COBASa_2.3.0

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·December 27, 2023

    Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.

    FDA Enforcement
    Class II ·Terminated·Inpeco S.A.·September 23, 2020

    FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.

    FDA Enforcement
    Class II ·Terminated·Inpeco S.A.·September 23, 2020

    Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.

    FDA Enforcement
    Class II ·Terminated·Inpeco S.A.·September 23, 2020

    E.M.S. Electro Medical Systems S.A.

    Manufacturer
    🇨🇭 Switzerland·10 Importers

    Ares Trading SA

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

    Acticore AG

    Manufacturer
    🇨🇭 Switzerland

    Kieser Training AG

    Manufacturer
    🇨🇭 Switzerland

    VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES

    Device
    EU MDR · Eu Md Class 1 ·IMT Analytics AG·On the market

    VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES

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

    SWISS PHARMA DYNAMIC LTD Zweigniederlassung

    Manufacturer
    🇨🇭 Switzerland·1 Basic UDI-DI·1 Device·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

    easypod 2

    Device
    EU MDR · Eu Md Class 2a ·Ares Trading SA·On the market·3 countries

    easypod 2

    Device
    EU MDR · Eu Md Class 2a ·Ares Trading SA·On the market·2 countries

    easypod 2

    Device
    EU MDR · Eu Md Class 2a ·Ares Trading SA·On the market·6 countries

    easypod 2

    Device
    EU MDR · Eu Md Class 2a ·Ares Trading SA·On the market·2 countries

    easypod 3

    Device
    EU MDR · Eu Md Class 2a ·Ares Trading SA·On the market·2 countries

    easypod 3

    Device
    EU MDR · Eu Md Class 2a ·Ares Trading SA·On the market·1 country

    easypod

    Device
    EU MDR · Eu Md Class 2a ·Ares Trading SA·On the market·6 countries

    RebiSmart

    Device
    EU MDR · Eu Md Class 2a ·Ares Trading SA·On the market·4 countries

    RebiSmart

    Device
    EU MDR · Eu Md Class 2a ·Ares Trading SA·On the market·2 countries