Securities code: 688617 Securities abbreviation: Huitai Medical Announcement No.: 2025-003

Shenzhen Huitai Medical Equipment Co., Ltd

Announcement on Voluntary Disclosure of Obtaining 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.

On January 24, 2025, Shenzhen Huitai Medical Device Co., Ltd. (hereinafter referred to as the "Company")

Obtain a medical device registration certificate, the details are as follows:

1. The specific situation of the medical device registration certificate

Name of registrant: Shenzhen Huitai Medical Device Co., Ltd

Product Name: Single-use magnetically positioned star-shaped mapping catheter

Registration Classification: Class III Active Medical Devices

Registration certificate number National Machinery Note 20253070229

This product is used in conjunction with electrophysiology mapping equipment in medical institutions for intracardiac electrophysiology marking

Intended Use Measure, record, and stimulate. Three-dimensional cardiac electrophysiological mapping produced with Shanghai Hongtong Industrial Co., Ltd

The system (model: HT-9000Pro, software release version V2) can also provide guidance when used together

Information on the location of the tube in the heart.

2. Impact on the company

The acquisition of the above-mentioned medical device registration certificate is conducive to enriching the company's product categories, expanding the company's product layout in the field of electrophysiology, continuously meeting diversified clinical needs, and further enhancing the company's core competitiveness.

3. Risk Warning

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 Shenzhen Huitai Medical Equipment Co., Ltd

January 27, 2025