Wuhan Ammunition Life-tech Co.,Ltd.

Wuhan Ammunition Life-tech Co., Ltd. specializes in diagnostic kits designed for molecular testing. Their products include plasma circulating free DNA (cfDNA) extraction and bisulfite conversion kits, stool DNA extraction and preservation devices, and cell-direct bisulfite modification kits. They also develop diagnostic tools like IHepcomf for hepatitis detection, IColocomf and IColohunter for colorectal cancer screening, and IEsohunter for detecting esophageal cancer-related biomarkers. These devices are primarily used for early detection and molecular analysis in clinical settings.

The company is headquartered in China. While the specific city or region isn’t detailed, the country of operation is clearly stated as CN (China). This location is relevant for understanding regulatory frameworks and market reach, particularly for devices intended for global or regional distribution.

The company’s devices are listed in the EUDAMED registry, which is the European database for medical devices. This registry is used to track and provide transparency on devices authorized within the European Union, including their classification and regulatory status. Listing here indicates compliance with EU requirements for In Vitro Diagnostic (IVD) devices.

The devices manufactured by Wuhan Ammunition Life-tech Co., Ltd. fall under Class A and In Vitro Diagnostic (IVD) General classifications. Class A devices are typically considered low-risk, while IVD General classification applies to diagnostic tests that do not fall into higher-risk categories like self-tests or devices used for infectious disease detection without specific risk mitigation. Classification determines regulatory pathways and post-market requirements.

IHepcomf is designed for detecting hepatitis-related biomarkers, likely aiding in the diagnosis or monitoring of hepatitis infections. IColocomf and IColohunter are tailored for colorectal cancer screening, using molecular testing to identify genetic markers associated with colorectal tumors. Meanwhile, IEsohunter focuses on esophageal cancer-related biomarkers, helping clinicians detect early signs of esophageal cancer through DNA analysis. These tools leverage molecular diagnostics to improve early detection and personalized patient care.