BIOMEDICAL DATA SOLUTIONS LIMITED

Biomedical Data Solutions Limited develops software applications for blood bank management and laboratory instrumentation, including tools for processing and analyzing test results in in vitro diagnostic (IVD) settings. Their products integrate with analysers to streamline workflows, such as the Procleix NAT Manager for nucleic acid testing and the Sanguin Liberty SRIMPORT for blood bank data handling. Additional software, like ORTHO CONNECT and cobas Synergy, supports laboratory operations by enabling data connectivity and reporting for diagnostic devices.

The company’s portfolio consists of Class II medical devices, which are regulated as moderate-risk products under the FDA’s classification system. These devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. regulatory requirements. The manufacturer operates from the United States, adhering to applicable FDA standards for software-as-a-medical-device (SaMD) applications in blood banking and laboratory diagnostics.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.