We are ISO 13485:2016 certified and GMP compliance. Manufacturing are performed in ISO 14644, ISO class 7 clean room environment. We have highest quality management system, strictly controlling various production details and the preservation of complete manufacturing records and documents.
We are an ISO 13485:2016–certified, GMP-compliant contract medical device manufacturer with a facility that features more than 20,000 square feet of manufacturing space, a Class 10,000 cleanroom, and model and prototype assembly labs. At CUUMED, we turn concepts into reality at our scalable manufacturing facility.
CUUMED has the expertise to supply clients with information and technology that can easily accommodate a wide variety of raw materials and product design requirements. CUUMED offers a comprehensive quality management system that covers design, manufacturing, packaging, labeling, distribution, installation, and storage.
ISO 13485:2016–certified and GMP-compliant
Our plant runs on a complete vertical integrated manufacturing process from raw material formation, compounding, tubing extrusion, tip forming/welding, hole punching and drilling, injection molding, printing to coating process, and the final assembly. We also have highly automated catheter manufacturing equipment, most of them developed in-house.
Our engineer and technician have over twenty years of experience in the medical materials and the development of medical catheters. Therefore, we can provide our clients with technical consultation service such as raw material selection, manufacturing technology, and most medical products design.
