SINOMED(SH:688108) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2026-02-04 22:44Core Viewpoint - The company has received a medical device registration certificate for its drug-eluting stent system, which is expected to enhance its product portfolio and market competitiveness [1][4]. Group 1: Medical Device Registration - The registration certificate number is 国械注准20263130263, and the product is a drug-eluting stent system [1]. - The drug-eluting stent system consists of a drug-coated stent made from L605 cobalt-chromium alloy and a rapid exchange balloon catheter delivery system [1][3]. - The drug-coated stent features a non-degradable bottom coating made of poly(butyl methacrylate) (PBuMA) and a biodegradable drug coating composed of rapamycin and poly(lactic-co-glycolic acid) (PLGA) [1][3]. - The drug dosage density is 1.20 μg/mm², with a drug loading range of 59 μg to 324 μg [1]. Group 2: Product Specifications - The product is suitable for blood vessels with diameters ranging from 2.25 mm to 4.00 mm for lesions ≤40 mm, and for diameters of 4.50 mm to 5.00 mm for lesions ≤30 mm, aimed at improving symptoms of ischemic heart disease [2]. - The product has a shelf life of 18 months and is sterilized using electron beam technology for single use [1][3]. Group 3: Impact on the Company - The approval of the drug-eluting stent system represents a significant achievement in the company's R&D efforts and is expected to accelerate the commercialization of its products [4]. - This product will enrich the company's product offerings, meet diverse market demands, and enhance its core competitiveness [4]. - The product is classified as a Class III medical device, and further production licensing is required before manufacturing can commence [4].