RADIANQBIO

RadiantBio specialises in cardiac monitoring devices, including implantable systems like the P-303 and P-701, which are designed for real-time electrophysiological data acquisition and arrhythmia detection. They also produce the Heart Guardian series, which appears to focus on long-term cardiac rhythm monitoring and diagnostic support.

RadiantBio is based in South Korea, as indicated by the company’s country of origin.

RadiantBio’s devices are listed in the EUDAMED database, which is the centralised system for tracking medical devices authorised within the European Economic Area. This registry ensures transparency and traceability of devices under EU regulatory oversight.

RadiantBio’s devices fall under EU Class IIb classification, which indicates a moderate risk level. This classification requires conformity assessment procedures under the EU Medical Device Regulation (MDR) to ensure their safety, performance, and compliance before they can be placed on the market.