EPITOMEE MEDICAL LTD

Epitomee Medical Ltd specializes in the Epitomee device, a medical instrument primarily used in radiology or interventional cardiology. It is designed for precise imaging or procedural guidance during minimally invasive techniques, such as coronary angiography or percutaneous interventions. The device falls under a specific category of medical tools tailored for diagnostic or interventional purposes.

Epitomee Medical Ltd is headquartered in Israel. The company’s location supports its operations in developing and distributing medical devices intended for use in radiology and interventional cardiology procedures.

Epitomee Medical Ltd’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This registration ensures compliance with European Union regulatory requirements and provides traceability for the devices under the EU Medical Device Regulation (MDR).

The Epitomee devices are classified as Class IIb under the EU Medical Device Regulation (MDR). This classification requires a rigorous conformity assessment process, including clinical evaluation and comprehensive risk management, to ensure their safety and performance before they can be placed on the market.