FFEI Limited

FFEI Limited specialises in automated pathology systems. Their primary device, the VENTANA DP 200, is designed for automated processing and staining of tissue samples in histopathology laboratories. This system streamlines workflows by ensuring precise and reproducible sample preparation, which is critical for accurate diagnostic analysis.

FFEI Limited is based in the United Kingdom (GB). Since the UK is part of the EU regulatory framework, its devices are subject to EU medical device regulations. The VENTANA DP 200 is classified as a Class A device, meaning it poses minimal risk and is subject to basic regulatory requirements, including registration in the EUDAMED database to ensure traceability and compliance with EU directives.

FFEI Limited’s devices, such as the VENTANA DP 200, are listed in the EUDAMED database. This registry is maintained by the European Union to track medical devices authorised under EU regulations. Listing in EUDAMED ensures transparency, allows healthcare providers to verify compliance, and supports post-market surveillance by regulatory authorities.

The VENTANA DP 200 is classified as a Class A medical device under EU regulations. This classification is determined by its intended purpose and risk level—Class A devices are considered low-risk, typically involving minimal or no invasive procedures. As a result, they require less stringent pre-market evaluation compared to higher-risk classes but still must meet essential safety and performance requirements before being placed on the market.