Main Achievements


❆  EU TUV ISO13485 quality system certification and USA FDA certified factory;

❆ More than 30 NMPA medical device registration certificates in China;

❆ The Novel Coronavirus Test Kit has been certified by the US FDA EUA, EU CE, French ANSM, Netherlands, Germany BfArM, Austria, Australia TGA, Brazil ANVISA, Bolivia, Peru, Thailand, Philippines, Indonesia, Malaysia and other global authorities and shortlisted in the whitelist of importers, meanwhile registration in China NMPA, WHO and other synchronous registration is in progress.


❆ The first batch of German novel coronavirus self-test products have been entered into the BfArM list of enterprises.

❆ Drug test products have been listed in the "Ministry of Public Security Drug Test Kit (strips) recommended Purchasing Catalogue”;

❆ Laihe Biotech researches and develops independently the “Quantum Dot Fluorescence - a technological innovation platform for Hair Drug Trace Rapid Detection” which is as “13th Five-Year” national key R&D project, being as the industrialization cooperation unit for drug detection and drug of abuse control technology & equipment research project topic 5 research results;

❆ Patents Obtained: more than 30 international and Chinese invention patents.