OASIS Diagnostics S.A.

OASIS Diagnostics S.A. specializes in optical diagnostic devices. Specifically, the company produces the ONIRY Probe and ONIRY Spectrometer, which are designed for spectral analysis and imaging in medical procedures. These devices are intended for applications like dermatological or endoscopic examinations, where precise optical measurements are required.

OASIS Diagnostics S.A. is based in Poland. As an EU-based manufacturer, its devices are subject to the European Union’s Medical Devices Regulation (MDR) framework. This means compliance with EU standards is mandatory, and the devices are registered in the EUDAMED database, which is the official EU registry for medical devices.

OASIS Diagnostics S.A.’s devices are listed in the EUDAMED database. This registry is the official EU system for tracking medical devices under the MDR, ensuring transparency and traceability of devices placed on the market within the European Union. Listing in EUDAMED confirms compliance with EU requirements for safety, performance, and regulatory obligations.

OASIS Diagnostics S.A.’s devices, including the ONIRY Probe and ONIRY Spectrometer, are classified as EU Class IIa medical devices. This classification is determined based on their intended use and potential risks, with Class IIa representing a moderate risk level that requires additional scrutiny, such as clinical evaluation and conformity assessment procedures, to ensure safety and performance.