Biosino Bio-Technology and Science Incorporation (Biosino Bio-Tech) announced that its subsidiary, Biosino Medical Instrument Technology (Jinan) Co., Ltd., has obtained Medical Device Registration Certificate No. Lu Xie Zhu Zhun 20262220227 from the Shandong Medical Products Administration. The approval clears the ZS-2000 Fully Automatic Biochemical Analyzer for commercial launch, sale and clinical use across mainland China between 16 April 2026 and 15 April 2031.
The ZS-2000 is designed for high-throughput clinical biochemical testing of human serum, plasma, whole blood, urine, cerebrospinal fluid, seminal plasma and fecal samples. Compatible reagent panels cover liver and renal function, ion metabolism, blood glucose, lipids, myocardial enzymes and immunochemical parameters; an optional module measures potassium, sodium and chloride electrolytes. Target end-users include hospital laboratories and third-party diagnostic centers seeking greater automation and cost efficiency.
Management highlighted that the certification strengthens the group’s “instrument + reagent” portfolio and complements the recently launched ZS-8600 chemistry-immunoassay integrated system, supporting deeper penetration of China’s medical testing market and potentially boosting reagent sales.
While the Board expects a positive contribution to the current year’s financial performance, it cautions that actual sales will depend on market conditions, tender outcomes, regulatory developments, competitive dynamics and broader macroeconomic factors. Shareholders and prospective investors are advised to exercise prudence when dealing in the company’s securities.