Deben Diagnostics Ltd

Deben Diagnostics Ltd specialises in in vitro diagnostic (IVD) antisera. Specifically, their products are designed for the detection of *Salmonella* and are intended for use in microbiological testing within clinical and research environments. These devices are developed to assist laboratories in identifying bacterial pathogens.

Deben Diagnostics Ltd is based in the United Kingdom. Since their devices are classified as IVDs under EU regulations, they must comply with EU IVD Directive or IVDR requirements. Being based in the UK allows them to participate in the EU market, and their devices are listed in the EUDAMED database, which is the official EU registry for medical devices.

Deben Diagnostics Ltd’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of IVDs, including their classification and compliance status under EU regulations.

Deben Diagnostics Ltd’s devices fall under the IVD General classification. This classification applies to in vitro diagnostics that do not pose significant risks and are intended for general use, such as their *Salmonella* antisera. The classification determines the regulatory requirements they must meet, including conformity assessment procedures.