Company Information
Independent technology development ability
Our capability of independent development of coatings, processes and equipment can meet the diversified coating requirements.We independently developed continuous grinding process.
Quality control system
The complete quality assurance system has been strictly implemented in-house.
Service ability
We have a robust customer-centric consciousness, and always try to create and deliver greater value for our clients.
| 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. |