Oriental Ocean subsidiary secures medical device approval for cardiac diagnostic kit

Shandong Oriental Ocean Sci-Tech Co., Ltd. announced that its wholly-owned subsidiary, AIVIC Bio-Technology Co., Ltd., has obtained a medical device registration certificate from the Shandong Provincial Medical Products Administration. The certificate is for the high-sensitivity cardiac troponin I (hs-cTnI) immunoassay kit (fluorescent immunoassay method), valid from December 11, 2025, to December 10, 2030. This kit is intended for in vitro quantitative detection of cardiac troponin I in human serum, plasma, and whole blood.

The company stated that the product’s approval enriches AIVIC Bio-Technology's product line in clinical testing. However, the impact on the company's performance in 2025 is expected to be minimal, and subsequent effects on future performance from the product’s production and sales are uncertain. Investors are advised to consider the risks, as the product has not yet entered production, and actual sales will depend on market expansion and demand.

Shandong Oriental Ocean Sci-Tech Co., Ltd. emphasized that it cannot currently predict the specific impact of the approved product on its future performance and will comply with all relevant information disclosure requirements. Investors are urged to exercise caution and be aware of investment risks.