Demax Products Gain CE Mark Certification Under MDR in Europe

September 5, 2024—Beijing Demax Medical Technology Co., Ltd., headquartered in China, announced European CE Mark certification in compliance with the European Union Medical Device Regulation (MDR) for five new products.

According to the company, the new products include (1) a thin-wall sheath for introducer sheath kits, (2) distal radial artery compression tourniquets, (3) peelable introducers with hemostasis valve, (4) a large-capacity (50/60 ml, 20 atm) balloon in-deflation device, and (5) percutaneous transluminal angioplasty balloon dilatation catheters for the 0.014-inch guidewire system.

These devices were independently developed and produced by Demax and have been rigorously reviewed to earn CE certification in compliance with the MDR, noted the company.