Hangzhou Lysun Biotechnology Co., Ltd. is located in Hangzhou Binjiang High-tech Zone. It is a high-tech biomedical enterprise specialized in the research and development, production and sales of IVD (in vitro diagnostic) reagents and supporting instruments.

Most of our R & D team members have more than 8 years of experience in POCT product development. They have already successfully optimized our products and are working on a new product development projects efficiently.

At present, we mainly focus on two areas of research: chronic disease health management and instant diagnostic reagents, they are extensively used in the fields of self-test, clinical biochemistry, and immunology.The main products are as follows:

• Blood Lipids Analysis Meter(Total Cholesterol, High-Density Lipoprotein Cholesterol, Triglycerides)

• Detection of infectious diseases (including COVID-19 detection products)

As a professional manufacturer and service provider in the IVD industry, Lysun plays a major role in the fields of biochemistry and immunology for both home and clinical use. Lysun has passed the EN ISO 13485:2016 quality management system certification. Relevant IVD products have obtained the EU CE certification.

Lysun is granted "white list" membership by the Chinese Ministry of Commerce for the anti-epidemic products exportation. At present, Lysun COVID-19 Antigen Rapid Test Device has been registered in many countries including Germany, France, Italy, Switzerland, Slovakia, Czech, Indonesia, Thailand, Malaysia etc., and passed the clinical validation in a national lab in Germany, Switzerland, Malaysia, etc. The products show good performance in sensitivity and specificity compared with industry-leading products and have been exported to more than 30 countries and regions.

	1- CE Certificate Identified by TUV SUD
	2- China Medical Device Registration Certificate (NMPA )for Glucose Uric Acid Analysis Meter
	3- China Medical Device Registration Certificate(NMPA ) for Dry Biochemical Analysis Meter
	4- China Medical Device Registration Certificate(NMPA ) for Hemoglobin Analysis Meter
	5- China Medical Device Registration Certificate(NMPA )for Glucose Analysis Meter
	6- Free Sale Certificate
	7- ISO9001: 2015 Certificate