CHONGQING, China, Feb. 28, 2026 -- SWS Medical officially announces that its flagship blood purification platforms, the SWS-4000 and SWS-6000 series hemodialysis machines and the SWS-5000 series continuous renal replacement therapy (CRRT) equipment, have received certification under the European Union Medical Device Regulation (EU MDR 2017/745).

Achieving compliance with the EU MDR—one of the world's most stringent regulatory frameworks for medical devices—marks a significant milestone in SWS Medical's global expansion. This certification guarantees uninterrupted market access across the European Economic Area (EEA) and validates the company’s fully integrated value chain spanning R&D, manufacturing, and global distribution.

The newly certified portfolio highlights SWS Medical's advanced technological capabilities and its strengthening position in the global blood purification market:

• The SWS-4000 and SWS-6000 Series: Representing China's leading dialysis technology, these machines deliver safer, more efficient treatments for end-stage renal disease (ESRD) through real-time monitoring and automated safety features. The SWS-6000 is equipped with certified monitoring of blood pressure, blood volume, temperature, and online clearance rate, while the SWS-4000 features an Online HDF system for personalized, on-demand sterile fluid production.

• The SWS-5000 Series: An award-winning, all-in-one platform supporting multi-organ blood purification, including the liver, kidneys, heart, lungs, and pancreas. As a critical care solution, it provides highly efficient continuous renal replacement therapy for patients in intensive care units.

About SWS Medical Based in Chongqing, China, SWS Medical is a publicly listed medical device company (STAR Market, SSE: 688410) specializing in blood purification solutions for dialysis and critical care. The company plays a leading role in advancing China's blood purification industry, chairing the China Blood Purification Industry Technology Innovation Strategic Alliance and contributing to the development of national and industry standards. SWS Medical operates globally, with products certified to international quality and regulatory standards, including CE marking and ISO 13485:2016 compliance.