33 New Certifications! Hotgen Biotech's EU IVDR CE Certifications Reach a Total of 78 Products, Accelerating Internationalization Progress!

Recently, 33 products independently developed by Beijing Hotgen Biotech have passed the EU IVDR CE certification. This CE IVDR certification was granted by one of Europe's most authoritative certification bodies, the British Standards Institution (BSI). As of February 6, 2025, Hotgen Biotech has accumulated a total of 78 products that have received EU IVDR CE certification.

The newly approved products cover Hotgen's main product lines, including CLIA immunoassay, up-converting phosphor technology, and colloidal gold, laying a solid foundation for further expansion into overseas markets. This achievement highlights Hotgen's relentless pursuit of aligning with international high standards.

The CE certification is a mandatory requirement for product access in the EU market, serving as a "visa" for products entering the European market. In 2022, the EU fully implemented the In Vitro Diagnostic Medical Devices Regulation (EU 2017/746, IVDR), which imposes stricter requirements on in vitro diagnostic manufacturers in areas such as technical documentation review, clinical evaluation, and post-market surveillance. This also indicates a further harmonization of medical device regulations across EU member states.

Moving forward, Hotgen Biotech will continue to uphold its innovation-driven development philosophy, increase investment in research and development, and launch more high-quality diagnostic products, contributing to the advancement of global healthcare.