SINOMED(SH:688108) Shang Hai Zheng Quan Bao·2026-01-09 21:01Core Viewpoint - The company, Sainuo Medical Technology Co., Ltd., has received registration certificates for its medical devices in Kazakhstan, marking a significant step in its international business expansion [1][8]. Product Registration Details - The HT Supreme™ drug-eluting stent system has been approved, which is a cobalt-chromium alloy stent with a biodegradable polymer layer for drug release, and has a shelf life of 18 months [1][5]. - The SC HONKYTONK™ coronary balloon dilation catheter, designed for the dilation of narrowed coronary arteries, has a shelf life of 3 years and is sterilized using ethylene oxide [3][6]. - The NC ROCKSTAR™ non-compliant balloon dilation catheter, also with a shelf life of 3 years, is intended for improving myocardial perfusion in patients with atherosclerosis [4][7]. Historical Context and Certifications - The HT Supreme™ stent is the first product from a Chinese manufacturer to undergo simultaneous clinical trials in China, the US, Japan, and Europe, receiving CE certification in December 2019 and various international registrations from 2022 to 2025 [5]. - The SC HONKYTONK™ catheter received its Chinese registration in December 2022 and has since gained multiple international certifications, including from the FDA [6]. - The NC ROCKSTAR™ catheter was registered in China in October 2022 and has also received various international certifications [7]. Impact on Company - The approval of these products for overseas markets is expected to enhance the company's sales and presence in international markets, although future performance may be influenced by regulatory policies, market conditions, and exchange rate fluctuations [8].