Announcement • Apr 21
Biosino Medical Instrument Technology (Jinan) Co., Ltd. Announces ZS-2000 Fully Automatic Biochemical Analyzer Obtaining Medical Device Registration Certificate for Market Launch
Biosino Bio-Technology and Science Incorporation announced that the ZS-2000 Fully Automatic Biochemical Analyzer, independently developed by Biosino Medical Instrument Technology (Jinan) Co. Ltd., a subsidiary of the Company, has recently obtained the Medical Device Registration Certificate for the PRC issued by the Shandong Medical Products Administration of the People’s Republic of China, marking that the product is qualified for legal launch, sale and use within the territory of the PRC. Product Name: Fully Automatic Biochemical Analyzer. Model: ZS-2000. Registration Certificate No.: LuXieZhuZhun20262220227. Validity Period of Registration: 16 April 2026 to 15 April 2031. Issuing Authority: Shandong Medical Products Administration. Intended Use: When used in conjunction with the supporting reagents, the product is clinically used for the quantitative analysis of clinical chemical components in human serum, plasma, whole blood, urine, cerebrospinal fluid, seminal plasma, and fecal samples, including liver function, renal function, ion metabolism, blood glucose, blood lipids, myocardial enzymes spectrum, and immunochemical parameters. When optionally equipped with an electrolyte analysis module, it can be used for the determination of potassium ions, sodium ions, and chloride ions electrolyte items in human serum. The ZS-2000 Fully Automatic Biochemical Analyzer is primarily used for clinical biochemical testing and can be widely applied in hospital clinical laboratories, third-party medical laboratories, and other medical testing institutions. It features high throughput, automation, and intelligence and others, which help improve testing efficiency and reduce operational costs. The obtaining of this registration certificate signifies a further enhancement of the Group’s technological strength in the field of high-end biochemical analytical instruments and marks the Group’s continuous improvement of its product portfolio in terms of the “instrument+reagent” integrated solution, which will help enhance the market competitiveness and brand influence of the Group’s products. The successful market launch of the ZS-2000 Fully Automatic Biochemical Analyzer, together with the collaborative launch of the ZS-8600 chemistry-immunoassay integrated system, will assist the Group in further expanding the domestic medical testing market and promoting the sales of related supporting reagent products, which is in line with the Group’s long-term development strategy. The obtaining of the above registration certificate is expected to have a positive impact on the financial position and operating result of the Group for the current year. The actual sales performance of the product in market may be subject to uncertainties arising from various factors including market conditions, bidding process, regulatory policies, competition landscape and macroeconomy. Shareholders and potential investors of the Company are advised to exercise caution when dealing in the securities of the Company.
