EasyMed Aura (Shenzhen) Medical Co., Ltd. is proud to hold ISO 13485:2016 certification (BSI Certificate No. MD 840204) for the manufacture and distribution of disposable non-sterile vascular and nonvascular guidewires.

This internationally recognized standard reflects our dedication to a certified Quality Management System, regulatory compliance, and continuous improvement. We put our customers first by delivering safe, reliable, and high-quality medical devices. Trust us to support better patient outcomes through excellence in every product we make.

Download ISO13485 Issued by BSI.pdf →

We operate strictly in accordance with the latest domestic and international standards.（ISO 13485 idt GB/T 42061、ISO 14971 idt GB/T 42062）《Medical devices — Application of risk management to medical devices》