Kehua Biotech: Announcement on Obtaining Medical Device Registration Certificate for Products
Securities code: 002022 Securities abbreviation: Kehua Biotechnology Announcement number: 2026-053 Shanghai Kehua Bioengineering Co., Ltd.
Announcement on Obtaining Medical Device Registration Certificate for Products
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete, and contains no false records, misleading statements or major omissions.
Recently, Kehua (Xi'an) Bioengineering Co., Ltd., a wholly-owned subsidiary of Shanghai Kehua Bioengineering Co., Ltd. (hereinafter referred to as the "Company"), received a medical device registration certificate (in vitro diagnostic reagent) from the Shaanxi Provincial Food and Drug Administration. The specific situation is as follows:
Serial number Product name Registration certificate number Registration certificate validity period Scope of application/intended use August 20, 2026 This kit is for use by medical institutions
Progesterone Determination Kit Shaanxi Machinery Injection Accurate
1 to In vitro quantitative determination of human serum samples (chemiluminescence method) 20262400148
August 19, 2031 The progesterone in the product is used for auxiliary diagnosis. This kit is for medical institutions to use D-Dimer August 20, 2026
Shaanxi Mechanical Injection In vitro quantitative determination of human plasma samples 2 assay kit to
D-Dimer (D-Dimer) in 20262400149 (Chemiluminescence method) August 19, 2031
Concentration, for auxiliary diagnosis.
The acquisition of the medical device registration certificate for the above new products has enriched the company's product line and will have a positive impact on the company's business development. The company is currently unable to predict the impact of the above products on the company's future operating income. Investors are advised to pay attention to investment risks.
Announcement is hereby made.
Board of Directors of Shanghai Kehua Bioengineering Co., Ltd.
August 25, 2026