Company Information
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.
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》
| Company | EasyMed Scientific (易术致慧（深圳）医疗器械有限公司) |
| Specialty | Guidewire OEM Manufacturing for Cardiovascular & Interventional Medical Devices |
| Certification | ISO 13485 Certified |
| Location | Shenzhen, China |
| Contact | sales@easymedscientific.cn |
| Certification | Details |
|---|---|
| ISO 13485:2016 | Medical Devices — Quality Management System. Certified for design and manufacturing of cardiovascular guidewires and interventional medical devices. |
| CE Marking (MDR) | Medical devices compliant with EU Medical Device Regulation (MDR) 2017/745 requirements. |
| FDA Registration | Establishment registration and device listing with the U.S. Food and Drug Administration. |
| Cleanroom Facility | Class 100,000 (ISO 8) cleanroom manufacturing environment for medical device production and assembly. |