Founded in November 2013, BIOHITHealthcare (Hefei) Co., Ltd. has always been committed to the development andapplication of in vitro diagnostic technology. The Company obtained the MedicalDevice Production License in 2016, and operates in strict accordance withthe ISO13485 quality management system. Through years of development, the Companyhas formed a complete industrialized system for the development, production andsales of in vitro diagnostic reagents and supporting instruments. The 15existing products have obtained CFDA CE certifications, and two of them are thefirst in the world.
The Company is positioned in thepreventive medicine field. Since its inception, the Company has carried outlong-term strategic cooperation with BIOHIT Oyj, a leading biomedical company inFinland, the in vitro diagnostictechnology of digestive diseases represented by serum gastric functions hasreached the internationally advanced level. In December 2018, in the oncologydiagnosis and treatment guidelines just released by the National HealthCommission of the People's Republic of China, the serum gastric detection isused as the only pathway to screen for gastric carcinoma. The relevantstandards are also built on the basis of BIOHIT products. In June 2018, the Company completed the share acquisition of Finnish BIOHIT Oyjand became the largest shareholder of BIOHIT Oyj, a listed company. Through this share acquisition, the Company hasfurther improved the industrial chain and laid the foundation for opening upthe global market. In 2016, the Company established an academician workstationto develop new tumor markers. Meanwhile, by cooperating with Germany's ScheBo·BiotechAG, the Company establish a diagnosis system based on digestive diseases. Thesenew original products are estimated to be available in the domestic market inone year.
In 2020, Biohit Healthcare (Hefei) Co.,Ltd. independently developed the SARS-CoV-2 rapid test kit, which has obtainedthe European Union CE certification, the United States - FDA, Australia - TGA,Brazil - ANVISA and other certifications of mutiple countries, and the kit isexported overseas.
BIOHIT Healthcare (Hefei) Co., Ltd. makescontinuous innovation in the field of preventive medicine. Withmulti-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.