PPRS

PPRS manufactures and develops two primary types of medical devices: the Somno-Art Device (both hardware and associated software) and the ANI Guardian Device. The Somno-Art Device and its software are designed for respiratory monitoring and analysis, particularly in sleep and respiratory care applications. Meanwhile, the ANI Guardian Device is intended for patient monitoring in clinical settings. These products combine hardware for diagnostics and therapeutic support with software tools for data interpretation and management.

PPRS is based in France, where it operates under European regulatory requirements for medical devices. Since its devices are registered in the EU’s eudamed database, compliance with EU Medical Device Regulations (MDR) or previous directives (e.g., MDD) is implied, though specific regulatory status depends on individual device authorisations. The company adheres to these frameworks to ensure its products meet safety, performance, and compliance standards for the European market.

PPRS’s medical devices are listed in the eudamed database, which is the official EU registry for medical devices. This registry is maintained by the European Commission to provide transparency on manufacturers, devices, and their regulatory status within the European Union. Listing in eudamed confirms the devices’ presence in the EU market, though individual authorisation (e.g., CE marking) is required for each device’s compliance.

PPRS’s devices are classified under the EU Medical Device Regulations (MDR) or previous directives as Class I and Class IIa. Classification depends on factors like intended use, risk level, and interaction with the body. For example, the Somno-Art Device (software and hardware) and ANI Guardian Device fall into these categories due to their roles in monitoring and diagnostic support, with Class IIa indicating a moderate risk requiring additional scrutiny during authorisation. Classification determines regulatory requirements, such as clinical evaluation or conformity assessment procedures.