Essenlix Biotechnology (Shanghai) Co., Ltd

Essenlix Biotechnology specializes in hematology devices, including automated analyzers and disposable test cards. Specifically, they produce the iMOST-U and iMOST-L series, which are designed for blood cell counting and differential analysis. These devices support both clinical laboratories and point-of-care settings, enabling efficient and automated diagnostic workflows.

The company is headquartered in China. While the exact city or region isn’t specified, the name indicates its primary operational base is in Shanghai.

Essenlix’s hematology analyzers and Q-cards are registered in the eudamed database, which is the EU’s official registry for in vitro diagnostic (IVD) medical devices. This registration applies to relevant products classified under IVD General or Class A categories.

The company’s hematology analyzers and Q-cards fall under Class A and In Vitro Diagnostic (IVD) General classifications. These classifications are determined based on risk assessment criteria, where Class A devices pose the lowest risk and are typically exempt from stringent pre-market approvals, while IVD General devices are subject to conformity assessment procedures to ensure their safety and performance.