Kehua Biotech: Announcement on Obtaining Medical Device Registration Certificate for Products
Securities code: 002022 Securities abbreviation: Kehua Biotech
Announcement Number: 2026-041 Bond Code: 128124 Bond Abbreviation: Kehua Convertible Bonds
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, Xi'an Tianlong Technology Co., Ltd., a holding subsidiary of Shanghai Kehua Bioengineering Co., Ltd. (hereinafter referred to as the "Company"), received a medical device registration certificate issued by the State 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
Based on the principles of magnetic bead nucleic acid extraction and real-time fluorescence PCR detection, fully automatic nucleic acid with supporting detection reagents July 10, 2026
Approved for joint use by the National Medical Instruments, clinically used for purification and amplification of source 1 to
20263221413 Target nucleic acid (DNA/RNA) in human samples enters the detection and analysis system July 9, 2031
Conduct qualitative and quantitative testing, including pathogens and
Human Genetic Testing Project.
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.
July 15, 2026