Anhui Deepblue Medical Receives EU IVDR Certificate for Self-Testing Products

HEFEI, China – May 22, 2026 – Anhui Deepblue Medical Technology Co., Ltd. has obtained the EU Technical Documentation Assessment Certificate under Regulation (EU) 2017/746 (IVDR).

The certified products include:

• SARS‑CoV‑2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)

• Influenza A+B & COVID‑19 (SARS‑CoV‑2) Antigen Test Kit (Colloidal Gold)

These tests are intended for non‑prescription home use with self‑collected nasal swab samples.

This certificate confirms that Deepblue Medical has met the technical documentation requirements of Annex IX, Chapter II of IVDR, a key step toward placing its self-testing rapid diagnostic products on the European market.

-------About Anhui Deepblue Medical
A national high‑tech enterprise focusing on R&D, production and sales of in vitro diagnostic reagents and medical devices.