FilingReader Intelligence

Snibe secures new medical device registration for bilirubin assay kit

October 13, 2025 at 10:09 AM UTCBy FilingReader AI

Shenzhen New Industries Biomedical Engineering Co. Ltd. ("the Company") recently announced it has obtained a new medical device registration certificate from the Guangdong Medical Products Administration. The certificate is for a Total Bilirubin (TBIL) Assay Kit (Diazo Salt Method), classified as Class II.

The assay kit is designed for in vitro quantitative determination of total bilirubin concentration in human (including neonate) serum or plasma. It primarily serves as an evaluation indicator for bilirubin metabolism disorders. The company noted that this product is a third-generation item.

With this latest addition, the Company has now accumulated 73 biochemical reagent medical device registration certificates, totaling 108 certificates. The acquisition enriches the Company's "liver function" project category within its biochemical detection products, which is expected to have a positive impact on the Company's development. However, the Company stated that it does not anticipate a significant impact on its recent production, operations, or performance, and advises investors to pay attention and be aware of investment risks.

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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