By December2025, HOKAPI has completed the IVDR registration process of 3rd wave CLIAreagents. In additionto the 4 new issued IVDR certificates this time (Gastrin-17, PIVKA-Ⅱ, Vitamin B12, Folate), HOKAPI hasacquired a total of 53 IVDR certificates for CLIA reagents. It strengthens our compliance layout for out of Chinamarket, laying a solid foundation for global market access. Newlyissued parameters precisely meets the core clinical needs The 4 parametersIVDR approved are indispensable in clini
September is indeed a harvest season.On September 26th, the unveiling ceremony of the BioMrieux R&D and Innovation Incubation Center (Suzhou) and the completion ceremony of the HOKAPI new site was held at the HOKAPI new site in Suzhou. The ceremony was hosted by Zhang Yunhong, General Manager of HOKAPI, and was jointly unveiled by Liu Xiaotao, Member of Standing Committee of CPC Jiangsu Provincial Committee, Party Secretary of CPC Suzhou Municipal Committee, Wang Yang, Member of Standing Com
Suzhou Hokapi Biomedical Engineering Co. Ltd. is co-founded by Suzhou Institute of Biomedical Engineering and Technology, Changchun Institute of Optics and Fine Mechanics and Physics, and natural person shareholder in 2009.
We are a high-tech enterprise focusing on R&D, manufacturing and sales of IVD products in China and worldwide. Our main products include automatic chemiluminescence immunoassay (CLIA) system and automatic blood grouping analyzers. We are dedicated to provide with high-quality IVD products for clinical diagnosis.
In November 2018, bioMérieux acquired a majority shareholding in Suzhou Hokapi Biomedical Engineering Co., Ltd and increased controlling share to 92.56% by October 2023. With this acquisition, HOKAPI has formed a strong team of professionals specialized in clinical laboratory instruments and IVD reagents to address healthcare needs.
