Demax Interventional Devices Gain European CE Certification Under MDR

May 10, 2024—Demax Group, a developer of cardiovascular devices for interventional procedures, announced it recently received CE certification in compliance with the European Union’s Medical Devices Regulation (MDR) for 11 lines of its interventional products. The Demax Group, which was established in 2004, develops, manufactures, and markets devices for coronary artery intervention, neurointervention, and percutaneous peripheral intervention.

As outlined by Demax, the 11 products include balloon in-deflation devices, introducer sheath kits, percutaneous transluminal angioplasty balloon dilatation catheters, radial artery compression tourniquets, a twist Y-connector kit, pressure lines, an interventional device set, peelable introducers, a push-click Y-connector kit, manifolds, and control syringes.

In July 2023, Demax announced that its independently developed and manufactured series of Gusta balloon dilation catheters for percutaneous transluminal coronary angioplasty received the CE Mark certificate in accordance with the MDR.

The company stated that the certification confirms the success of its transitional plan from the previous Medical Device Directive to the MDR CE certification. This achievement, which comes after a thorough auditing process, signifies that its devices have met all necessary requirements and maintains the products’ availability in Europe and other markets that recognize CE Mark.