Beijing Healthgene Laboratory Co., Ltd

Beijing Healthgene Laboratory Co., Ltd specializes in in vitro diagnostic (IVD) tests and kits, focusing on nucleic acid detection reagents. Their portfolio includes molecular diagnostics tools like the COVID-19 Nucleic Acid Detection Kit, which uses fluorescence PCR technology, and genetic testing kits such as the FMR1 CGG PCR assay. These products are designed for laboratory use to identify infectious diseases and genetic markers.

The company is headquartered in China, specifically in Beijing. This location reflects its focus on developing and producing diagnostic tools tailored to global laboratory needs, including those used for infectious disease screening and genetic analysis.

Beijing Healthgene Laboratory Co., Ltd’s devices are listed in the eudamed database, which is the EU’s official registry for in vitro diagnostic (IVD) medical devices. Listing in eudamed demonstrates compliance with EU regulatory requirements for IVD General category devices, ensuring transparency and adherence to diagnostic standards.

The company’s devices fall under the IVD General classification category. This classification applies to in vitro diagnostics that pose minimal risk, such as nucleic acid detection kits and genetic testing assays, which are designed for laboratory use to detect specific biological markers or pathogens without invasive procedures.