Shenzhen Hainwise Achieves First CE MDR Certification for PTCA Guidewire

Shenzhen Hainwise Medical Technology Co., Ltd., a leading innovator in the medical device sector, has achieved a groundbreaking milestone by securing the first-ever CE MDR (Medical Device Regulation) certification for its PTCA (Percutaneous Transluminal Coronary Angioplasty) guidewire. This certification, granted by BSI (British Standards Institution), represents a significant leap forward for the company and sets a new benchmark for the medical device industry.

The PTCA guidewire is a critical component in coronary intervention procedures, used to guide and navigate catheters through the coronary arteries. This CE MDR certification is a recognition of Hainwise’s commitment to producing high-quality, safe, and effective medical devices. It ensures that the PTCA guidewire meets the rigorous standards set by the European Union's medical device regulations, which focus on patient safety, clinical performance, and quality management.

This achievement is not only a testament to Shenzhen Hainwise's technical capabilities but also underscores the company’s dedication to advancing medical technology and improving patient care worldwide. By obtaining this prestigious certification, Hainwise has reaffirmed its position as a leader in the medical device field, particularly in the cardiovascular sector.

The company’s PTCA guidewire has undergone extensive testing and clinical evaluations, confirming its compliance with EU medical standards. With this certification, Hainwise now has the authorization to market and sell its PTCA guidewire throughout the European Union and other international markets that recognize CE certification.

Shenzhen Hainwise Medical Technology, headquartered in Shenzhen, Guangdong, China, continues to push the boundaries of medical innovation. This achievement in obtaining the CE MDR certification adds to their growing portfolio of certified products, which aim to meet the evolving demands of the global medical community. The company remains committed to its mission of delivering cutting-edge medical devices that improve the quality of life for patients around the world.

This certification marks a key turning point for Shenzhen Hainwise Medical Technology, opening new doors for expansion and establishing the company as a trusted name in the global medical device market.