Hefei, China – March 2025 — Anhui Deepblue Medical Technology Co., Ltd. is pleased to announce that its SARS-CoV-2 & Influenza A/B Antigen Combo Self-Test Kit (Colloidal Gold) has officially received the EU Technical Documentation Assessment Certificate under REGULATION (EU) 2017/746 on In Vitro Diagnostic Devices (IVDR).

The certification, issued by the EU Notified Body Sertio Oy, verifies that the product meets the stringent regulatory requirements outlined in Annex IX, Chapter II of the IVDR. This significant achievement affirms that Deepblue Medical’s self-testing solution has passed rigorous evaluations of safety, performance, and technical documentation.

The three-in-one self-test kit is designed to detect SARS-CoV-2, Influenza A, and Influenza B antigens with high accuracy and speed. It empowers individuals to conduct reliable testing in non-clinical settings, facilitating early identification of respiratory infections and aiding in timely isolation and treatment decisions.

This EU certification marks a major milestone for Deepblue Medical as the company continues to expand its presence in the European diagnostic market. It also underscores the company’s ongoing commitment to delivering high-quality, accessible, and regulatory-compliant diagnostic solutions globally.

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About Anhui Deepblue Medical Technology Co., Ltd.

Anhui Deepblue Medical Technology Co., Ltd., headquartered in Hefei, China, is a leading manufacturer of rapid diagnostic tests. The company offers a wide range of solutions in women’s health, infectious disease detection, cardiovascular diagnostics, tumor markers, PCR testing, and drug screening. With global regulatory certifications and a strong focus on innovation, Deepblue Medical is dedicated to improving diagnostic efficiency and public health worldwide.