Shenzhen Hainwise Achieves First CE MDR Certification for PTCA Guidewire

Shenzhen Hainwise Medical Technology Co., Ltd., a leading innovator in medical devices, has achieved a significant milestone by obtaining the first CE MDR (Medical Device Regulation) certification for its PTCA (Percutaneous Transluminal Coronary Angioplasty) guidewire. The certification, issued by BSI (British Standards Institution), underscores the company's commitment to quality, safety, and clinical performance.

The PTCA guidewire is a critical tool in coronary interventions, guiding and navigating catheters through coronary arteries during angioplasty procedures. CE MDR certification confirms that Hainwise’s guidewire complies with stringent European Union medical device standards, including patient safety, clinical effectiveness, and quality management requirements.

This achievement demonstrates Hainwise's technical capabilities and dedication to advancing cardiovascular medical technology. The PTCA guidewire underwent extensive testing and clinical evaluations to ensure compliance with EU regulations. With this certification, Hainwise is authorized to market and sell its PTCA guidewire across the European Union and in other international markets that recognize CE certification.

Headquartered in Shenzhen, Guangdong, China, Hainwise continues to expand its portfolio of certified medical devices. The company remains focused on delivering innovative cardiovascular solutions that improve patient outcomes and procedural efficiency globally.

Obtaining CE MDR certification represents a pivotal milestone for Hainwise, enhancing its international credibility, supporting market expansion, and solidifying its position as a trusted name in the global medical device industry.