Pumen Technology: Shenzhen Pumen Technology Co., Ltd. Announcement on Voluntary Disclosure of Obtaining Medical Device Registration Certificate
DATE:  Apr 12 2025

Securities code: 688389 Securities abbreviation: Pumen Technology Announcement No.: 2025-031

Shenzhen Pumen Technology Co., Ltd

Announcement on Voluntary Disclosure of Obtaining Medical Device Registration Certificate

The board of directors and all directors of the company guarantee that the content of this announcement does not contain any false records and misleading statements

or material omissions, and bear legal responsibility for the authenticity, accuracy and completeness of its content in accordance with law.

Shenzhen Pumen Technology Co., Ltd. (hereinafter referred to as the "Company") has recently received the "Medical Device Registration Certificate of the People's Republic of China (in vitro diagnostic reagent)" issued by three Guangdong Provincial Drug Administrations, the details are as follows:

1. The specific situation of the medical device registration certificate

Serial Number Product Name Registration Registration Certificate Registration Certificate Intended Use

Category Number Valid Until

Full-scale C-reactive protein is used for the quantitative determination of human serum and blood in vitro

(Hypersensitive CRP+ Conventional Cantonese Injection 2030 C-reactive protein in plasma and whole blood samples.)

1 CRP) assay kit class II 20252400478 04/06 content, clinically used for non-specific inflammation

( Rate scattering turbidity and adjunct diagnosis of cardiovascular disease.)

Act)

serum amyloid A 2030 This product is used in the company's serum amyloid

2 (SAA) Controls Class II 20252400507 04/07 Protein A (SAA) Assay Kit and Fit

In-house quality control with instruments.

serum amyloid A 2030 This product is used in the company's serum amyloid

3 (SAA) Calibrator Class II 20252400508 04/07 Protein A (SAA) Assay Kit and Fit

Calibration with the instrument.

2. Impact on the company

The products that have obtained the registration certificate this time are all suitable for specific protein analyzers in the company's in vitro diagnostic product line.

Among them, the C-reactive protein (CRP) in the sample can be compared with the full-scale C-reactive protein assay kit (rate scatter ratio

Antigen-antibody sensitized latex particles in the turbidity method) undergo antigen-antibody immune reaction, forming an insoluble complex, which is scattered when the light passes through the reaction suspension and detected by a specific protein analyzer, and the rate of change of scattered light intensity is proportional to the concentration of CRP in the sample, and the content of CRP in the sample can be obtained by comparing with the standard curve.

The acquisition of the above-mentioned product registration certificate further enriches and improves the product categories of the company's in vitro diagnostic product line, which will help enhance the company's core competitiveness in the field of in vitro diagnostics.

3. Risk Warning

The acquisition of the above-mentioned registration certificate only represents the company's related products to obtain domestic market access qualifications, and the actual sales of the products after listing depend on the promotion effect of the future market, and it is not yet possible to predict the specific impact of the above-mentioned products on the company's future performance.

Investors are advised to invest rationally and pay attention to investment risks.

The announcement is hereby made.

Board of Directors of Shenzhen Pumen Technology Co., Ltd

April 12, 2025

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