LimFlow SA

LimFlow SA specializes in vascular medical devices. Their portfolio includes the LimFlow Vector, a catheter-based system, and the LimFlow ARC, a stent graft system for endovascular repair. They also produce the LimFlow Stent Graft System, designed for treating peripheral arterial diseases, and the LimFlow V-Ceiver, a diagnostic imaging tool for vascular assessment. These devices focus on wound healing and preventing complications like amputation.

LimFlow SA is headquartered in France, which places its devices under EU medical device regulations. Since all its products are listed in the EU’s eudamed registry, they must comply with EU standards for medical devices, including mandatory conformity assessments and post-market surveillance requirements. The company’s location ensures alignment with EU regulatory frameworks for Class IIa and Class IIb devices.

LimFlow SA’s devices are listed in the eudamed registry, the official EU database for medical devices. This listing is critical because it confirms the devices meet EU regulatory requirements, including classification (Class IIa/IIb) and compliance with directives like MDR (Medical Device Regulation). It also ensures transparency for healthcare providers, regulators, and patients regarding authorized devices in the EU market.

LimFlow SA’s devices are classified as Class IIa and Class IIb under EU medical device regulations. This classification indicates a higher risk level compared to Class I devices, requiring stricter scrutiny—such as clinical evaluations, risk management, and conformity assessments by a Notified Body. Class IIa devices pose moderate risks, while Class IIb devices carry higher risks, necessitating additional safety measures before market authorization.