Wondfo Biologics’ subsidiary receives medical device registration certificate

August 3, 2025  Source: drugdu 54

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On July 29, Wondfo Biotech(300482) announced that its wholly-owned subsidiary, Shenzhen Tianshen Medical EquipmentCo., Ltd. recently received medical device registration certificates issued by the State Food and Drug Administration and the Guangdong Provincial Food and Drug Administration .

The approved products include multiple test kits, primarily used for the quantitative determination of relevant components in blood, and clinically used to assist in the diagnosis of various diseases. Specifically approved products include a tissue plasminogen activator-inhibitor 1 complex assay kit, a fibrinogen degradation product assay kit, and a plasmin-α2 plasmin inhibitor complex assay kit.

These products, valid until 2030, cover the detection of thrombotic diseases and tumor markers, providing a richer testing menu for clinicians. The company stated that it will actively promote the sales of these products in the future, but it is currently unable to predict the specific impact of these products on the company's performance.

In the first quarter of 2025, Wondfo Biologics achieved revenue of 800 million yuan and net profit attributable to shareholders of the parent company of 189 million yuan.

Source:https://finance.eastmoney.com/a/202507293470282646.html

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