/Kehua Biotech: Announcement on Obtaining Medical Device Registration Certificate for Products
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Kehua Biotech: Announcement on Obtaining Medical Device Registration Certificate for Products

Shenzhen Stock Exchange
2026/08/06

Securities code: 002022 Securities abbreviation: Kehua Biotechnology Announcement number: 2026-049 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, Shanghai Kehua Bioengineering Co., Ltd. (hereinafter referred to as the "Company") received the medical device registration certificate (in vitro diagnostic reagent) 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 August 4, 2026 This kit is used for in vitro qualitative testing

Neisseria gonorrhoeae nucleic acid detection kit approved by the National Medical Products Administration

1 to test male urethral swab and female cervix (PCR-fluorescence method) 20263401679

August 3, 2031 Gonococcal nucleic acid in swab samples.

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 6, 2026