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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Country: Switzerland ×

    IMT Analytics AG

    Manufacturer
    🇨🇭 Switzerland·2 Basic UDI-DIs·2 Devices·1 Importer

    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

    SeedIMPULSE SA

    Manufacturer
    🇨🇭 Switzerland·1 Basic UDI-DI·1 Device·ITALCERT SRL

    Specht Upgrade

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

    EZplan

    Device
    EU MDD · Eu Md Class 1 ·SeedIMPULSE SA·On the market

    Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·June 10, 2020

    Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - Product Usage: 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 systems consolidate multiple Analytical instruments into a unified workstation.

    FDA Enforcement
    Class II ·Terminated·Inpeco S.A.·June 3, 2020

    Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·May 13, 2020

    Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio 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 systems consolidate multiple Analytical instruments into a unified workstation.

    FDA Enforcement
    Class II ·Terminated·Inpeco S.A.·November 18, 2020

    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·October 20, 2021

    Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 FLX-207-00, FLX-207-01, FLX-207-02, FLX-230-00, FLX-230-01, FLX-230-02 FLX-207-10, FLX-207-11, FLX-230-10

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·May 10, 2023

    EasyLung Neonatal

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·IMT Analytics AG·1 device

    EasyLung

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·IMT Analytics AG·1 device

    Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·May 10, 2023

    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

    Woodpecker rasping machine surgical add-on tool

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·IMT Integral Medizintechnik AG·1 device

    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing,

    FDA Enforcement
    Class II ·Terminated·Inpeco S.A.·November 7, 2018

    EZplan

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·SeedIMPULSE SA·1 device

    399-00-00-DM

    Certificate
    MDD Annex II (excluding section 4)·SeedIMPULSE SA·ITALCERT SRL·1 Basic UDI-DI