Xiamen Zhixuan Biotech Co., Ltd

Xiamen Zhixuan Biotech Co., Ltd specializes in nucleic acid extraction kits. Their portfolio includes the MagPure Circulating DNA Kit, designed for isolating circulating DNA from blood samples, and the Universal DNA Library Prep Kit, used for preparing DNA libraries for sequencing. They also offer the VanGenes product line, which appears to support genetic analysis or sample preparation.

The company is headquartered in China, specifically in Xiamen. This location is relevant for understanding regulatory pathways, manufacturing standards, and compliance frameworks applicable to their devices.

Xiamen Zhixuan Biotech Co., Ltd’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. Listing in EUDAMED is required for devices placed on the EU market, ensuring traceability and compliance with EU regulations.

All of Xiamen Zhixuan Biotech Co., Ltd’s listed devices fall under Class A classification in the EU Medical Device Regulation (MDR). Class A devices are generally considered to pose the lowest risk, often involving minimal or non-invasive procedures, and typically require less stringent clinical evidence for compliance.