Founded in November 2013, BIOHIT Healthcare (Hefei) Co., Ltd. has always been committed to the development and application of in vitro diagnostic technology. The Company obtained the Medical Device Production License in 2016, and operates in strict accordance with the ISO13485 quality management system. Through years of development, the Company has formed a complete industrialized system for the development, production and sales of in vitro diagnostic reagents and supporting instruments. The 15 existing products have obtained CFDA CE certifications, of these products, some have reached the international advanced level. The Company is positioned in the preventive medicine field. Since its inception, the Company has carried out long-term strategic cooperation with BIOHIT Oyj, a leading biomedical company in Finland. Through independent innovation, the in vitro diagnostic technology of digestive diseases represented by serum gastric functions has reached the internationally advanced level. In December 2018, in the oncology diagnosis and treatment guidelines just released by the National Health Commission of the People’s Republic of China, the serum gastric detection is used as the only pathway to screen for gastric carcinoma. The relevant standards are also built on the basis of BIOHIT products. In June 2018, the Company completed the acquisition of Finnish BIOHIT Oyj and became the largest shareholder of BIOHIT Oyj, a listed company. Through this merger and acquisition, the Company has further improved the industrial chain and laid the foundation for opening up the global market. In 2016, the Company established an academician workstation to develop new tumor markers. Meanwhile, by cooperating with Germany’s ScheBo·Biotech AG, the Company establish a diagnosis system based on digestive diseases. These new original products are estimated to be available in the domestic market in one year.
On March 18, 2020, (SARS-CoV-2)IgM/IgG Antibody Rapid Test Kit passed the European CE certification and export qualifications. The registration of the US FDA and Australian TGA is also in progress. In order to better serve the prevention and control of SARS-CoV-2 (COVID-19), we look forward to the clinical verification led by the World Health Organization and avoid application confusion caused by the quality difference of test kits. BIOHIT Healthcare (Hefei) Co., Ltd. makes continuous innovation in the field of preventive medicine. With multi-disciplinary integration as the means and core technology as the support, the Company provides the society with innovative products that are affordable, useful and worthwhile, and offers considerate health care services.