Shandong Oriental Ocean's AVICO Bio-Tech secures medical device approval

Shandong Oriental Ocean Sci-Tech announced that its wholly-owned subsidiary, AVICO Bio-Tech Co., Ltd., has obtained a medical device registration certificate from the Shandong Provincial Drug Administration. The certificate is for its self-developed fully automatic chemiluminescence immunoassay analyzer.

The certificate, valid from September 15, 2025, to September 14, 2030, enhances AVICO Bio-Tech's product line in clinical testing. The analyzer is designed for detecting various analytes in human samples, including pathogenic antigens, antibodies, tumor-associated antigens, proteins, hormones, enzymes, lipids, vitamins, autoantibodies, and allergens.

The company cautioned investors that the impact of this approval on AVICO Bio-Tech's performance in 2025 is expected to be minimal. The product has not yet entered production, and its actual sales performance is subject to market expansion and demand, making the future financial impact uncertain. Investors are advised to exercise caution due to these inherent risks.