Better2Know

Better2Know specialises in rapid, point-of-care testing devices for sexually transmitted infections (STIs) and HIV. These devices are designed to provide on-site results within minutes, enabling immediate clinical decision-making in settings like primary care and sexual health clinics. The portfolio includes systems for testing blood and fluid samples, focusing on simplicity and efficiency for healthcare providers.

Better2Know is based in the United Kingdom. While the company’s primary focus is the UK market, its devices are developed to comply with EU regulatory standards, which may facilitate use in other European countries where applicable regulations align. However, specific market authorisations depend on individual country requirements.

Better2Know’s devices are registered in euDAMED, the official EU database for medical devices. This registry is required for in vitro diagnostic (IVD) devices under EU regulations, ensuring transparency and traceability of products authorised for use within the European Economic Area.

Better2Know’s devices are classified as Class A under EU regulations for in vitro diagnostics (IVDR). This classification is determined by the risk associated with the device’s intended use and performance. Class A devices generally pose the lowest risk and require conformity assessment procedures, including technical documentation and manufacturer declarations, to demonstrate compliance with EU safety and performance standards.