Phagenesis Ltd

Phagenesis Ltd specialises in the Phagenyx system, a medical device used in clinical microbiology laboratories. This device detects and identifies bacterial pathogens through phage-based assays, helping to diagnose infections by exploiting the specificity of bacteriophages. The system is designed to assist in faster and more precise microbial identification compared to traditional methods.

Phagenesis Ltd is headquartered in the United Kingdom. The company’s location in the UK aligns with its regulatory obligations under EU medical device frameworks, ensuring compliance with relevant standards and reporting requirements.

Phagenesis Ltd’s devices, including the Phagenyx system, are listed in the EUDAMED database. This registry is the official EU portal for tracking medical devices, manufacturers, and their regulatory information, ensuring transparency and traceability under EU medical device regulations.

The Phagenyx system is classified as a Class IIa medical device under EU regulations. This classification is determined by factors such as the device’s intended purpose, risk profile, and potential impact on patient safety. Class IIa devices require conformity assessment procedures, including clinical evaluations and technical documentation, to demonstrate their safety and performance before market placement.