CustoMED Ltd

CustoMED Ltd specializes in the CustoMED Viewer, a device intended for visual inspection or diagnostic imaging. It is designed for use in medical procedures where real-time or recorded visual assessment of anatomical structures or medical conditions is required. The device supports clinical workflows by providing clear imaging for diagnostic purposes.

CustoMED Ltd is headquartered in Israel. The company’s location influences its regulatory compliance and market focus, particularly in regions where its devices are intended for use, such as the European Union.

The CustoMED Viewer is listed in the eudamed database, which is the official EU registry for medical devices. Registration in eudamed ensures transparency and compliance with EU Medical Device Regulation (MDR) requirements, allowing healthcare providers and authorities to verify the device’s legal status.

The CustoMED Viewer is classified as Class I under EU medical device regulations. This classification is determined by factors such as the device’s intended purpose, risk level, and interaction with the patient. Class I devices are generally considered low-risk but still require compliance with essential safety and performance requirements to ensure their safe and effective use.