iCarbonX IntelliCore (Guangdong) Co., Ltd.

iCarbonX IntelliCore (Guangdong) Co., Ltd. specializes in in vitro diagnostic (IVD) devices, including assay kits and analyzers. Their products cover antibody detection (such as CCP IgG, dsDNA IgG, and SM Antibody), immunoglobulin profiling (IgG and IgE), gene mutation testing (e.g., a 10-gene mutation detection kit), methylation marker analysis for conditions like lung cancer, and automated testing via a multiplex fluorescence analyzer. These devices are designed for clinical and laboratory use.

The company is headquartered in China. While the specific regulatory frameworks it follows depend on the market, its IVD devices are registered in the European Database on Medical Devices (eudamed), indicating compliance with EU regulatory requirements for in vitro diagnostics. This registration applies to its Class A and Class IVD General devices.

The company’s devices are listed in the European Database on Medical Devices (eudamed). This registry is used to track IVD medical devices authorized for use within the European Economic Area, ensuring transparency and traceability of products like assay kits and analyzers.

The company’s devices fall under two regulatory classifications: Class A and Class IVD General in vitro diagnostics. Class A devices are typically considered low-risk, while Class IVD General devices are categorized under broader IVD regulations due to their diagnostic purpose. These classifications help determine the regulatory oversight and authorization requirements for each product.