Company Information
Founded in March 2025 with a registered capital of HK$10 million in Shenzhen, we are a wholly-owned subsidiary of EasyMed Medical Co., Ltd. from Hong Kong.
We are a leading dedicated OEM manufacturer of guidewires for minimally invasive interventional procedures. In China, we might be the largest OEM manufacturer of guidewires by the end of 2027, when the second-phase factory is set up.
A strict quality management system has been established and in operation here.The ISO 13485 certification issued by BSI will surely be obtained between May and June 2026.We have a 10,000-Class clean room complying with GMP requirements.（ ISO 14644-1、YY/T 0033 ）
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. |