Company Information
Our state-of-the-art laboratory is equipped with a comprehensive suite of specialized facilities, meticulously designed to meet the highest international standards of quality and safety. These include a Positive control room, a Microbial Limit Testing Room, a Physical testing room, a Primary changing room and a Hydrophilic Coating room-4, all working in synergy to enable rigorous scientific research and reliable testing outcomes.
Our manufacturing facility covers an area of approximately 4,000 square meters, housing workshops like cleaning, extrusion molding, injection molding, coating, assembly and other processes.
Our factory is equipped with an R&D laboratory, a physical and chemical laboratory, a precision instrument room, and 3 biology laboratories(Sterility Testing Laboratory, Positive Control Room, Microbial Limit Testing Room).
| 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. |