Hangzhou Lysun Biotechnology Co., Ltd

Hangzhou Lysun Biotechnology Co., Ltd specializes in in-vitro diagnostic (IVD) devices. Their portfolio includes hemoglobin analysis meters and multi-function analyzers designed for self-testing, such as meters that measure blood glucose, uric acid, blood lipids, and blood pressure. These devices are intended for point-of-care use, allowing users to perform tests outside traditional clinical settings.

The company is based in China (CN). While the specific location within China isn’t detailed, the country of origin is relevant for regulatory and compliance purposes, particularly when assessing device classification and market access requirements.

Yes, some of Hangzhou Lysun Biotechnology Co., Ltd’s devices are listed in the EU’s eudamed registry. This registry is used to track IVD devices placed on the European market, ensuring transparency and traceability for regulatory oversight. Listing in eudamed is voluntary but helps demonstrate compliance with EU IVD regulations.

Hangzhou Lysun Biotechnology Co., Ltd’s devices fall under Class A classification and are categorized as IVD devices for self-testing, as well as general IVD devices. Class A devices are typically considered low-risk, but they still must meet regulatory requirements to ensure safety, performance, and proper labeling. Self-testing IVDs require additional considerations, such as user-friendliness and risk mitigation for home use.

The inclusion of devices in eudamed depends on whether they are placed on the European market under EU IVD Regulations. If a device is marketed in the EU—even if only in limited quantities—it may be listed in eudamed. Other devices may not be marketed in the EU or may fall outside the scope of mandatory registration, such as those exclusively sold in non-EU regions. The registry reflects active market presence rather than the company’s entire product portfolio.