Hangzhou Laihe Biotech Co., Ltd.

Hangzhou Laihe Biotech Co., Ltd. was founded in 2012 by a medical doctor who studied in the United States, and the team is mainly composed of research-oriented and knowledge-based personnel. Located in Binjiang District, Hangzhou, the company has 10,000 square meters of office, R&D, and production space. It has always focused on R&D and industrialization in the fields of POCT instant diagnostics, monitoring, and health information technology, and is committed to providing the public with fast, accurate, and reliable in vitro diagnostic products and services. It is a national high-tech enterprise integrating R&D, production, and sales.
It has obtained 24 medical device product registration certificates approved by China's National Medical Products Administration and 30 patents of various types at home and abroad. The company's COVID-19 IgG/IgM antibody detection kit has obtained registrations in more than ten countries and regions, including EU CE, Australia TGA, U.S. FDA EUA, Brazil ANVISA, and Philippines FDA, and is currently applying for registration with China's National Medical Products Administration (NMPA) and WHO EUL. The COVID-19 antigen detection kit has obtained EU CE registration and Indonesia registration. The COVID-19 antigen test (home self-test) was one of the first three companies to receive emergency authorization from the German Ministry of Health on February 24, 2021. It is currently applying for FDA EUA and WHO EUL registrations. Products are sold to more than 40 countries, including the United States, Germany, France, Italy, the United Kingdom, Brazil, South Africa, Russia, and Peru.
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