FilingReader Intelligence

Shandong Oriental Ocean subsidiary gets medical device registration for detection reagent

December 16, 2025 at 05:14 AM UTCBy FilingReader AI

Shandong Oriental Ocean Sci-Tech Co., Ltd. announced that its subsidiary, Mass Spectrometry Biotechnology Co., Ltd., has obtained a medical device registration certificate from the Shandong Provincial Drug Administration. The approval is for the "Methotrexate Detection Reagent (Liquid Chromatography-Tandem Mass Spectrometry)" and is valid from December 11, 2025, to December 10, 2030. This new product is designed for the in vitro quantitative detection of methotrexate levels in human serum or plasma.

The company highlighted that the newly approved product further enriches Mass Spectrometry Biotechnology's product line in the clinical detection field. However, Shandong Oriental Ocean Sci-Tech cautioned investors that the impact of this product on the company's performance in the current year is expected to be minimal.

Investors are advised to be aware of potential risks as the product has not yet entered production, and its actual sales performance will be subject to market expansion efforts and demand. The company stated it cannot currently predict the specific impact on future financial performance and will strictly adhere to information disclosure requirements.

This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com

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