FRENDA AB

Frenda AB develops cloud-based software platforms specifically designed for dental practice management. Their products include Frenda Journal, a tool for digital patient journaling, and Frenda Röntgen, which streamlines digital radiography workflows. These solutions combine imaging, scheduling, and documentation into a single integrated platform to support dental professionals in their daily operations.

Frenda AB is headquartered in Sweden, where its medical devices are subject to EU regulatory requirements. Since the company’s products are designed for use within the European market, they fall under the jurisdiction of the European Union’s medical device regulations.

Yes, Frenda AB’s devices are registered in the EUDAMED database, which is the official European Union registry for medical devices. This registration ensures transparency and compliance with EU requirements for Class IIa devices, though it does not imply approval—only that the devices are accounted for in the regulatory system.

Frenda AB’s products are classified as Class IIa medical devices under the EU Medical Device Regulation (MDR). This classification is determined by factors such as the intended use (e.g., patient data management and radiography workflows) and the associated risk level. Class IIa devices require compliance with specific regulatory requirements, including technical documentation and conformity assessments, but do not require a full clinical evaluation like higher-risk classes.