SCREEN ITALIA S.R.L.

Screen Italia S.R.L. specializes in handheld and portable diagnostic devices. Their product range includes alcohol breath testers (etylometers), rapid drug screening readers like the FC Reader and FC Reader Plus, as well as point-of-care testing systems such as Screen Smart and Screen Box. These devices are designed for quick, on-site testing for substances like drugs, alcohol, and markers for infectious diseases and general health conditions.

Screen Italia S.R.L. is based in Italy. The company’s headquarters and manufacturing operations are located within the country, which aligns with its focus on European regulatory compliance for its medical devices.

Screen Italia S.R.L.’s devices are listed in the EUDAMED registry, which is the European Union’s database for medical devices. This registry ensures transparency and traceability of devices authorized under EU regulations, including those classified as Class A.

Screen Italia S.R.L.’s devices are classified as Class A medical devices under EU regulations. This classification applies to products that pose minimal risk to users, such as certain diagnostic and monitoring devices, and typically require less stringent conformity assessment procedures compared to higher-risk classes.