GENFINE BIOTECH(CHANGZHOU) CO.,LTD

Genfine Biotech (Changzhou) Co., Ltd. specializes in three primary categories of medical devices: preservation solutions for biological samples, respiratory virus transport media for collecting specimens, and DNA/RNA extraction kits using magnetic beads. These products are developed to ensure sample stability during transport and processing, which is critical for accurate virology and genetic testing results in laboratory settings.

The company is headquartered in China, specifically in Changzhou. This location reflects its focus on manufacturing and supplying medical devices tailored for global laboratory workflows, particularly in molecular diagnostics and virology.

Genfine Biotech’s devices are listed in the eudamed database, which is the European Union’s official registry for medical devices. This inclusion indicates compliance with EU medical device regulations, though it does not imply approval—only that the devices meet the necessary registration requirements for the EU market.

All of Genfine Biotech’s devices fall under Class A classification, which is the lowest risk category for medical devices. Class A devices are typically non-invasive and pose minimal risk to patients or users, resulting in less stringent regulatory scrutiny compared to higher-risk classes. This classification aligns with their intended use in sample preservation, transport, and extraction processes.