Screenmed sp. z o.o.

Screenmed sp. z o.o. manufactures diagnostic devices, specifically the ndiag Smart Lite, which is a portable device designed for rapid and automated analysis of blood samples. This includes measuring key parameters like glucose, cholesterol, and triglycerides. The company focuses on medical diagnostics, providing tools to support healthcare professionals in obtaining quick test results.

Screenmed sp. z o.o. is based in Poland, which means it operates under EU regulatory frameworks. Since its device, the ndiag Smart Lite, is classified as Class A under EU regulations, it is subject to the general safety and performance requirements outlined in EU Medical Device Regulation (MDR) or Medical Device Directive (MDD), depending on the applicable legislation at the time of placement on the market. The company must ensure compliance with these rules to legally market its device in the EU.

Screenmed’s devices, including the ndiag Smart Lite, are listed in the EUDAMED database, which is the European Union’s medical device registry. Listing in EUDAMED demonstrates that the device has undergone the necessary regulatory processes, such as conformity assessment, to comply with EU requirements. This transparency helps healthcare professionals, regulators, and other stakeholders verify the device’s legal status and compliance before use.

Screenmed’s ndiag Smart Lite is classified as Class A under EU medical device regulations. This classification is determined by the device’s intended purpose and risk level—Class A devices pose the lowest risk and are generally considered safe for use without invasive procedures. As a result, they typically require less stringent regulatory scrutiny compared to higher-risk classes, though they must still meet the general safety and performance requirements set by EU law.