Bgi Europe A/S

BGI Europe A/S manufactures in vitro diagnostic (IVD) kits and software for nucleic acid extraction, pathogen detection, genetic mutation analysis, and methylation testing. Key products include kits for HPV typing, EGFR/KRAS/ALK gene mutation detection, and chromosome aneuploidy analysis, alongside software tools for cancer mutation analysis and pathogen identification. The company also provides liquid chromatography-tandem mass spectrometry-based kits for amino acid and carnitine detection.

These devices fall under Class A and IVD Annex II List B classifications, with some listed under IVD General regulations. The products are registered in the EU’s eudamed database. The manufacturer is based in Denmark.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

As the founder of the Chinese gene industry, and with its mission of “genetic science and technology for the benefit of humanity”, China has developed a network of marketing services covering more than 100 countries and autonomous regions of all provinces and cities around the world, becoming a small number of industry-wide, applied technology companies, a technologically advanced, well-equipped and large-scaled multi-group-output platform, which has become an invaluable provider of science and technology and provider of accurate medical services worldwide。

Translated from the manufacturer's own website. Source