CE certification is a mandatory safety certification system implemented by the EU. It is known as "Conformité Européene" and its core purpose is to ensure that products in the EU market comply with basic requirements for health, safety, and environmental protection. It is a necessary condition for products to legally enter the 27 member states of the EU and the 4 countries of the European Free Trade Area. The certification standards are strict, with high requirements for product technical parameters, quality control, and risk prevention. The products that Lysun obtained this certification have undergone strict product testing, risk assessment, and technical document review, fully demonstrating the company's outstanding capabilities in product research and development, production, and manufacturing.
As a high-tech biopharmaceutical enterprise specializing in the research, production and sales of in vitro diagnostic reagents and related instruments, Lysun has been deeply engaged in the IVD field for many years. The core R&D team members have over 8 years of experience in the development of POCT products. They always strictly control product quality at a high standard. Their products have passed the EN ISO 13485:2016 quality management system certification and cover categories such as blood glucose monitors, lipid analyzers, and infectious disease tests, and are widely used in home self-testing, clinical biochemistry, and other fields. The acquisition of this first CE certificate is not only an authoritative recognition by the EU of Lysun's product strength and compliance capabilities, but also an important opportunity for the company to break through international market barriers and participate in global competition.
According to the relevant person in charge of Lysun, this certification process was carried out strictly in accordance with the relevant EU directives and harmonized standards. The team meticulously prepared technical documents, including product descriptions, design drawings, risk assessment reports, test reports and other core materials. They actively cooperated with the certification agency to complete the entire process of review and testing. Eventually, the certification was successfully passed. The person in charge stated that the acquisition of the first CE certificate is an important milestone in the company's globalization strategy. It will further enhance the international influence of the brand and lay a solid foundation for the expansion of the product market in Europe.
Looking to the future, Lysun will take this first CE certification as an opportunity to continue to deepen product research and development and quality improvement, and accelerate the global expansion strategy. The company has clearly stated that it will steadily advance the CE certification work of other core products according to the established plan. It is expected that by the end of 2026, all other types of in vitro diagnostic products under the company's portfolio will have completed their CE certification, achieving full coverage of the EU market for the core product line. This will further expand the international market territory, provide customers with higher-quality and more compliant in vitro diagnostic products and services, and help Chinese manufacturing go global.