United Imaging Healthcare: Announcement on the Voluntary Information Disclosure of Shanghai United Imaging Medical Technology Co., Ltd. on Obtaining the Medical Device Registration Certificate
DATE:  Apr 08 2025

Stock code: 688271 Stock abbreviation: United Imaging Medical Announcement No.: 2025-006

Shanghai United Imaging Medical Technology Co., Ltd

Announcement on the Voluntary Information Disclosure of Obtaining the Medical Device Registration Certificate

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 in accordance with the law.

In order to facilitate investors to understand the company's recent business situation, the medical device registration certificate obtained by the company in domestic and major overseas markets from 2025 to the present is hereby announced as follows:

Category Product Name Product Model Valid Until

Medical angiography X-ray machine uAngio 960 X December 29, 2027

Magnetic Resonance Imaging System uMR 600 Max March 11, 2030

NMPA Magnetic Resonance Imaging System uMR 670 Max March 25, 2030

Positron emission X-ray computed tomography

uMI Panvivo March 31, 2030

Like the system

Radiation Therapy Contouring Software uIPW December 29, 2029

Radiation Therapy Planning System uTPS OmniplanTx December 29, 2029

CE

Positron emission and X-ray computed tomography

uMI Panvivo March 1, 2029

Imaging scanning system

By the end of the first quarter of 2025, the company has registered in more than 80 countries and regions worldwide, and has accumulated products

More than 140 products have been approved for marketing, of which 49 products have obtained FDA certificates and 49 products have obtained CE certification

Certificates, including the completion of the full line of uMI Panorama products, and the uMR Jupiter has become the most complete product in the world

It is the only full-body human clinical ultra-high-field magnetic resonance imaging (UHFM) that is licensed by both NMPA, FDA and CE. In 2024

The company's strategic innovative products have been launched one after another, such as the uLinac HalosTx precision radiotherapy system and the uMR Max new one

New products such as the generation 3.0T magnetic resonance and uAngio AVIVA intelligent suspension DSA have been released, systematically verifying the public

The company's integration advantages in the technology ecology of the whole industry chain of "core components - complete machine system - intelligent platform".

With a full range of high-performance products, the company has achieved sales in more than 85 countries and regions around the world. According to the differentiated characteristics of different overseas countries and regions, the company develops products that meet local needs, promotes product registration in different countries and regions, and expands the types of products that can be sold overseas.

The acquisition of the above-mentioned medical device registration certificate is conducive to enriching the company's product categories, continuously meeting diversified clinical needs, and further enhancing the company's core competitiveness. The actual sales of the above products depend on the promotion effect of the future market, and the company is currently unable to predict the impact of the above products on the company's future operating income.

The announcement is hereby made.

Board of Directors of Shanghai United Imaging Medical Technology Co., Ltd

April 8, 2025

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