USP Class VI, ISO 10993 biocompatibility evaluation, and ISO 13485:2016 quality system certification, manufactured at an FDA-registered facility

DONGGUAN, China, June 16, 2026 /PRNewswire/ -- Dongguan Ruixiang Precision Silicone Products Co., Ltd. (Ruixiang Silicone) has released a platinum-cured medical-grade silicone tubing series manufactured at an FDA-registered facility and carrying USP Class VI certification, ISO 10993 biocompatibility evaluation, and ISO 13485:2016 quality management system certification. The product is intended for use as fluid transfer components in extracorporeal cardiac assist systems, micro-infusion systems, and hemodialysis equipment, where tubing comes into direct contact with drug solutions or extracorporeal circulation pathways.

The release addresses a material problem that has persisted in conventional peroxide-cured silicone tubing. During peroxide vulcanization, the decomposition of peroxide initiators generates residual byproducts within the crosslinked matrix. When post-cure processing fails to remove these residuals completely, they gradually migrate out of the tubing matrix and into any fluid in contact with it. In drug delivery contexts, this leaching introduces contaminants into fluids in contact with the tubing. Over time, the same residuals cause the visible yellowing and surface blooming that indicate a peroxide-cured tube is no longer serviceable. Ruixiang Silicone's platinum-catalyzed addition cure process generates no such residual byproducts. The reaction proceeds through direct addition chemistry, in which vinyl and hydride siloxane groups combine to form new carbon-silicon bonds without releasing any small-molecule byproducts. Because no residuals are produced in the first place, no high-temperature post-cure cycle is required. For medical device manufacturers evaluating peroxide cure versus platinum cure silicone tubing for regulated applications, this distinction directly affects material qualification documentation requirements.

The practical result is tubing that remains colorless and transparent through extended storage and repeated autoclave sterilization. The optical clarity of the tubing also enables visual inspection of fluid lines during operation.

Dimensional Tolerances and Process

In peristaltic pump applications, wall distribution inconsistency translates directly to flow rate error over thousands of operating hours. Ruixiang Silicone holds inner and outer diameter tolerances to ±0.02 mm using a vertical extrusion process, where gravity-assisted material flow supports consistent wall distribution across the tube cross-section. The minimum processable inner diameter is 0.14 mm with a wall thickness floor of 0.1 mm. These specifications bring the product into range for micro-catheter assembly and precision infusion device manufacturing.

Production runs through GMP-compliant cleanrooms rated at ISO Class 8 (Class 100,000) and Class 300,000 per Chinese national standard GB 50073, inside a 5,000 m² facility in Dongguan, Guangdong Province.

Regulatory Certifications

Ruixiang Silicone's platinum-cured medical silicone tubing carries the following certifications:

USP Class VI: highest classification in the USP plastics testing series, required for medical consumable supply chain qualification in North America.
ISO 10993: biocompatibility evaluation per international medical device framework, the primary reference standard for European market qualification.
ISO 13485:2016: quality management system certification for medical device manufacturing.
FDA-registered facility: manufacturing site registered with the U.S. Food and Drug Administration.

"Cardiac assist and hemodialysis procurement teams run long qualification cycles. The biocompatibility and extraction data they require takes time to generate regardless of who the supplier is. We completed that process on the platinum-cure line so customers entering those device categories are working with material that already carries the documentation. At the dimensional tolerances this product operates at, wall distribution inconsistency is not recoverable in post-processing. The vertical extrusion line was built around that constraint from the start." 

— Feng Zhen Huang, CEO of Ruixiang Silicone.

About Ruixiang Silicone

Ruixiang Silicone is a Dongguan-based manufacturer of platinum-cured medical-grade silicone tubing and components, founded in 2012. The company serves extracorporeal cardiac assist systems, micro-infusion, hemodialysis, GMP biopharmaceutical, and food-grade fluid handling applications across more than 50 countries. Its products carry USP Class VI, ISO 13485:2016, LFGB, RoHS, and REACH certifications, are manufactured at an FDA-registered facility, and are biocompatibility evaluated per ISO 10993. Standard prototype turnaround for OEM and ODM customers is 48 hours. Ruixiang Silicone reports over 5,000 enterprise clients across medical device, biopharmaceutical, and food-grade fluid handling sectors.

Website: www.medicalsiliconetube.com

Media Contact
Olivia Ou
Dongguan Ruixiang Precision Silicone Products Co., Ltd.
Email: olivia@dgruixiang.com
Tel: +86 18819110575