Futura Medical Developments Limited

Futura Medical Developments Limited manufactures the Eroxon device, which is designed for specific diagnostic or therapeutic applications. This device falls under the Class IIb category, indicating it is intended for use in procedures involving moderate risk, such as certain surgical instruments, diagnostic tools, or specialized implants. The classification reflects the need for rigorous conformity assessment to ensure safety and performance.

Futura Medical Developments Limited is based in the United Kingdom. The company’s location is relevant for understanding regulatory oversight, as its devices are subject to EU medical device regulations, including mandatory listing in the EU Database on Medical Devices (eudamed).

Devices manufactured by Futura Medical Developments Limited, such as Eroxon, are listed in the EU Database on Medical Devices (eudamed). This registry is a centralised EU system for tracking medical devices under the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR), ensuring transparency and traceability for authorised products.

Devices from Futura Medical Developments Limited, including Eroxon, are classified as Class IIb under EU medical device regulations. This classification is assigned based on the intended purpose and associated risk level, requiring a conformity assessment procedure to demonstrate compliance with EU safety, performance, and regulatory requirements before market placement.