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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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