MGI: Announcement on the Acquisition of Medical Device Registration Certificate and Voluntary Disclosure of Gene Sequencer Products of a Wholly-owned Subsidiary
DATE:  Jan 14 2025

Stock code: 688114 Stock abbreviation: MGI Announcement No.: 2025-001

Shenzhen MGI Technology Co., Ltd

Regarding the wholly-owned subsidiary's gene sequencer products, it obtained the medical device registration certificate and

Announcement of Voluntary Disclosure

The board of directors and all directors of the company guarantee that there are no false records, misleading statements or material omissions in the content of this announcement, and assume legal responsibility for the authenticity, accuracy and completeness of its content.

Qingdao MGI Technology Co., Ltd., a wholly-owned subsidiary of Shenzhen MGI Technology Co., Ltd. (hereinafter referred to as the "Company"), has recently obtained the medical device registration certificate of the People's Republic of China for its gene sequencer products, as follows:

1. Basic information of the registered product

Name of registrant: Qingdao MGI Technology Co., Ltd

Registration certificate number National Machinery Note 20253220056

Product Name: Gene Sequencer

Model and specification: DNBSEQ-E25

Scope of application The product uses combined probe-anchored polymerization sequencing technology, which is used in clinical practice for human-derived samples

The human DNA is sequenced to detect the gene sequences that these genetif sequences

Columns can be used to aid in diagnosing disease or disease susceptibility. The instrument is clinically limited to the use of national medicines

In vitro diagnostic reagents and software approved by the quality supervision and management department are used together, and are not used for human use

Sequencing or de novo sequencing of the genome.

Issuing authority: State Drug Administration

Valid from 10 January 2025 to 9 January 2030

2. Impact on the company

The acquisition of the above-mentioned medical device registration certificate is conducive to the comprehensive development of the gene sequencer business of the company and its subsidiaries, which will further improve the comprehensive competitiveness of the company and its subsidiaries, and have a positive impact on the sustainable development of the company and its subsidiaries.

3. Risk Warning

The actual sales of the above products are affected by various factors such as market demand and market competition, and the company is currently unable to predict its impact on the company's future performance. Investors are advised to make prudent decisions and pay attention to investment risks.

The announcement is hereby made.

Shenzhen MGI Technology Co., Ltd

board of directors

January 14, 2025

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