Hefei, China – March 2025 — Anhui DEEPBLUE Medical Technology Co., Ltd. is proud to announce that our innovative SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold) has officially obtained the European Union In Vitro Diagnostic Regulation (IVDR) certificates, including both the Self-Testing Certificate and the Quality Management System (QMS) Certificate.

The certifications were issued by the notified body Sertio Oy, confirming compliance with REGULATION (EU) 2017/746. These certificates demonstrate that DEEPBLUE Medical's 5 in 1 antigen combo test kit meets the stringent requirements of Annex IX for Technical Documentation Assessment and Quality Management Systems under IVDR.

This 5 in 1 combo test kit is designed to simultaneously detect SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Adenovirus (ADV) antigens, offering rapid and reliable results to support early diagnosis and timely medical intervention. The successful acquisition of these EU certifications not only affirms DEEPBLUE Medical’s commitment to product quality, safety, and compliance but also enhances the accessibility of our diagnostic solutions across European markets.

With a robust quality system and cutting-edge diagnostic technologies, DEEPBLUE Medical continues to uphold the highest international standards, providing trusted rapid testing solutions for global healthcare needs.

For more information, please visit our website or contact us directly.