Company Information
Corporate culture
Precision & Wisdom
Vision & Action
Inclusiveness& Accessibility
Excellence & Longevity
We are committed to R&D and production of high-quality interventional medical consumables, providing customers with reliable products they can trust.
| 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. |