Suzhou Precigenome Ltd, Co;

Suzhou Precigenome Ltd manufactures diagnostic tools primarily focused on molecular testing. Their devices include digital PCR kits for detecting pathogenic microorganisms (such as sepsis-related infections) and genetic mutations (e.g., PIK3CA 11 mutations and JAK2 V617F mutations). They also produce PCR amplification apparatus, portable PCR instruments (capable of processing 16 samples at once), and biochip scanners for automated analysis. These products are designed for both research and clinical use, particularly in infectious disease and oncology workflows.

Suzhou Precigenome Ltd is based in China. The company develops and distributes its devices from this location, ensuring compliance with relevant regulatory standards for diagnostic medical devices in China and markets like the European Union.

Some of Suzhou Precigenome Ltd’s devices are listed in the EU’s eudamed registry, which is the official database for in vitro diagnostic (IVD) medical devices authorized in the European Economic Area. This registry helps healthcare professionals and regulators verify the presence of devices on the market.

Suzhou Precigenome Ltd’s devices fall under Class A and In Vitro Diagnostic (IVD) General classifications. Class A devices are typically considered low-risk, while IVD General classifications apply to diagnostic tools that do not fall into higher-risk categories (e.g., self-tests or devices detecting infectious agents). These classifications help determine regulatory pathways and compliance requirements.