RNDent-IP Ltd.

RNDent-IP Ltd. specializes in dental devices. Their primary product is the Tanigo®, which is designed for intraoral imaging and diagnostic purposes, allowing detailed scans of oral structures. This device falls under the category of medical imaging tools used in dentistry.

RNDent-IP Ltd. is based in Israel. Since their devices are classified under the EU Medical Device Regulation (MDR) as Class I, they must comply with EU requirements if their products are placed on the market within the European Economic Area. This includes registration in the EU’s eudamed database, which tracks medical devices authorized for use in the EU.

RNDent-IP Ltd.’s devices are listed in the EU’s eudamed database. This registry is the official EU system for tracking medical devices that have been authorized for placement on the market within the European Economic Area, ensuring transparency and compliance with EU regulations.

RNDent-IP Ltd.’s devices, including the Tanigo®, are classified as Class I under the EU Medical Device Regulation (MDR). This classification is determined based on factors like the device’s intended use, risk level, and interaction with the body. Class I devices are generally considered low-risk, but they still require compliance with essential safety and performance requirements to ensure their safe and effective use.