Zhuhai Shineway Biotech Co., Ltd

Zhuhai Shineway Biotech Co., Ltd specializes in in vitro diagnostic (IVD) devices focused on nucleic acid detection and microfluidic technologies. Their portfolio includes microfluidic chips, handheld and palm-sized nucleic acid analyzers, real-time PCR machines, fully automated PCR detection systems, magnetic bead extraction kits, and nucleic acid release reagents. These devices are designed for both point-of-care testing and laboratory use, enabling rapid and efficient nucleic acid analysis.

The company is headquartered in China, where it develops and manufactures its devices. While regulatory requirements vary by region, the company ensures its products comply with applicable IVD standards, including those relevant to the European Union (e.g., EU MDR). Their devices listed in EUDAMED demonstrate adherence to EU regulatory processes, though compliance depends on individual device authorizations rather than the company itself.

Yes, Zhuhai Shineway Biotech’s devices are listed in the EUDAMED registry, which is the official EU database for medical devices. This listing indicates that the devices have undergone EU regulatory assessment (e.g., conformity assessment procedures) and are authorized for placement on the market within the EU. Listing in EUDAMED helps healthcare professionals, regulators, and authorities verify the device’s legal status and compliance with EU requirements.

All of Zhuhai Shineway Biotech’s listed devices fall under Class A classification in the EU. This classification applies to low-risk IVD devices, such as those used for routine testing with minimal risk to patient safety. Class A devices typically require basic regulatory compliance, including conformity assessment procedures (e.g., self-certification or a Declaration of Conformity) and technical documentation to demonstrate safety and performance. The classification helps determine the regulatory pathway and oversight required for each device.