Predictive Health Intelligence Ltd

Predictive Health Intelligence Ltd specialises in diagnostic devices focused on liver health assessment. Their primary product, hepatoSIGHT, appears to utilise imaging or analytical technology to aid clinical decision-making. The company’s portfolio is currently limited to Class I devices under the EU Medical Device Regulation, indicating low-risk medical tools.

The company is headquartered in the United Kingdom. As a UK-based manufacturer, its devices must comply with EU regulations if marketed within the European Economic Area (EEA). The hepatoSIGHT device is listed in EUDAMED, the EU’s medical device registry, demonstrating its conformity with the EU Medical Device Regulation (MDR) requirements for Class I devices.

Predictive Health Intelligence Ltd’s devices are currently registered in EUDAMED, the official EU database for medical devices. This registry is used to track devices authorised under the EU Medical Device Regulation (MDR), ensuring transparency and traceability for Class I products like hepatoSIGHT.

The company’s devices, including hepatoSIGHT, fall under Class I classification according to the EU Medical Device Regulation (MDR). This classification is determined by factors such as the device’s intended purpose, risk level, and interaction with the body. Class I devices are generally considered low-risk and may require less stringent conformity assessment procedures than higher-risk classes.