Jiuqiang Biotech: Announcement on the Company’s Products Obtaining IVDR CE Certification
Securities code: 300406 Securities abbreviation: Jiuqiang Biotech Announcement number: 2025-078 Bond code: 123150 Bond abbreviation: Jiuqiang Convertible Bonds
Beijing Jiuqiang Biotechnology Co., Ltd.
Announcement on the Company’s Products Obtaining IVDR CE Certification
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.
Six products of Beijing Jiuqiang Biotechnology Co., Ltd. (hereinafter referred to as the "Company") have recently obtained EU IVDR CE certification. The details are as follows:
1. Basic information of certified products
Serial number Product name Validity period Certificate number Intended use
D-dimer assay kit (gel for in vitro quantitative determination of human blood 1 2030-09-10 HX2165478-1
Milk immunoturbidimetric method) D-dimer content in slurry. Potassium determination kit (pyruvate shock) for in vitro quantitative determination of human blood 2 2030-09-10 HX2165478-1
Enzymatic method) Potassium content in serum or plasma. Sodium determination kit (galactoside for in vitro quantitative determination of human blood 3 2030-09-10 HX2165478-1
Enzymatic method) Sodium content in serum or plasma.
Determination kit for in vitro quantitative determination of total bile acids in human blood (circulation
4 2030-09-10 HX2165478-1 Cyclic enzyme method for total bile acids in serum or plasma)
content.
High-density lipoprotein cholesterol test is used for the in vitro quantitative determination of white cholesterol content in human blood (direct method - peroxygen 2030-09-10 HX2165478-1 high-density lipoprotein enzyme clearance method in plasma). Low-density lipoprotein cholesterol test kit is used for the in vitro quantitative determination of the white cholesterol content in human blood serum or plasma.
2. Impact on the company and risk warning
The new EU In Vitro Diagnostic Medical Device Regulations (IVDR, EU2017/746) have replaced the original EU In Vitro Diagnostic Medical Devices Directive (IVDD, 98/79/EC) to manage in vitro diagnostic medical devices in the EU market.
The acquisition of the IVDR CE certificate this time shows that the company's related products comply with EU requirements and have the necessary conditions to enter the EU market, which is conducive to meeting the diverse clinical needs of customers in the international market and further enhances the comprehensive competitiveness of the company's products. The company will actively expand dealers and overseas sales, but it is currently impossible to predict its impact on the company's future performance. Investors are advised to pay attention to investment risks.
Announcement is hereby made.
Board of Directors of Beijing Jiuqiang Biotechnology Co., Ltd.
September 17, 2025