Wuxi Opulen Technology Co.,Ltd.

Wuxi Opulen Technology Co., Ltd. specializes in real-time fluorescence quantitative PCR instruments and devices, such as the HyperLyse system. These devices are designed for nucleic acid amplification and detection, enabling precise quantification of DNA or RNA in clinical and research applications. They are primarily used for genetic analysis and pathogen detection.

The company is based in China (CN). Its devices are registered in the EUDAQS database through the eudamed portal, which is the official European Union registry for medical devices. This registration ensures transparency and compliance with EU regulatory requirements for listed devices.

The devices produced by Wuxi Opulen Technology Co., Ltd. fall under Class A classification in the EU. This classification is typically assigned to low-risk medical devices, such as certain in vitro diagnostic (IVD) instruments, based on their intended use and risk profile as defined by EU medical device regulations.

The registration in eudamed specifically pertains to compliance with EU regulatory requirements, meaning these devices are intended for use within the European market. While the company may market similar products globally, the eudamed listing confirms their authorised status under EU regulations for that region.