According to Pumen Technology's announcement, the company's H100plus hemoglobin testing system has obtained approval from the US FDA 510. The marketing number is K260468. The regulatory category is Class II. The approval period is October 2, 2026. The intended use is to quantitatively detect glycated hemoglobin content in a person's whole blood in vitro, which can assist in the diagnosis of diabetes. The approval of this product indicates that it meets the relevant requirements of the US FDA and has US market entry qualifications, which is conducive to enhancing the company's overall competitiveness in overseas markets and has a positive effect on international business development. The actual sales situation is affected by many factors, and it is currently impossible to predict the specific impact on future results.
Zhitongcaijing · 1d ago
Share
Listen to the news
According to Pumen Technology's announcement, the company's H100plus hemoglobin testing system has obtained approval from the US FDA 510. The marketing number is K260468. The regulatory category is Class II. The approval period is October 2, 2026. The intended use is to quantitatively detect glycated hemoglobin content in a person's whole blood in vitro, which can assist in the diagnosis of diabetes. The approval of this product indicates that it meets the relevant requirements of the US FDA and has US market entry qualifications, which is conducive to enhancing the company's overall competitiveness in overseas markets and has a positive effect on international business development. The actual sales situation is affected by many factors, and it is currently impossible to predict the specific impact on future results.
Disclaimer:Webull uses external vendor Google Translation Service for news translations where we endeavour to ensure these are correct, however, we recommend that you please double-check this information accordingly. Webull is not responsible for translation errors or issues.
What's Trending