Preventicus GmbH

Preventicus GmbH develops digital health solutions focused on continuous heart rhythm monitoring. Their portfolio includes mobile applications like the Preventicus Heartbeats App, wearable devices such as the Preventicus Nightwatch, and systems like the Preventicus Coach and Preventicus 360°, which provide ECG-quality rhythm tracking. The Preventicus Heartbeats Core serves as a foundational hardware component for these systems, enabling automated rhythm analysis and alerts for potential irregularities.

Preventicus GmbH is based in Germany. Its devices are designed to comply with EU medical device regulations, including requirements for software-as-a-medical-device (SaMD) and connected health technologies. Classification under these regulations determines the level of scrutiny and documentation required for market placement.

Preventicus GmbH’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. Listing in EUDAMED is mandatory for manufacturers to demonstrate compliance with EU regulatory requirements and transparency in the medical device supply chain.

Preventicus GmbH’s devices are classified as Class I and Class IIa under EU medical device regulations. Classification is determined by factors like intended use, risk level, and interaction with the body. Class I devices pose minimal risk, while Class IIa devices involve moderate risk and require additional scrutiny, such as clinical evaluations or conformity assessments.