Securities code: 688617 Securities abbreviation: Huitai Medical Announcement No.: 2025-007

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 major 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 February 26, 2025, Shenzhen Huitai Medical Device Co., Ltd. (hereinafter referred to as the "Company")

Hunan Epte Medical Device Co., Ltd., a wholly-owned subsidiary, has obtained a medical device registration certificate, as follows:

1. The specific situation of the medical device registration certificate

Name of registrant: Hunan Epte Medical Device Co., Ltd

Product Name: Single-use magnetically positioned pressure monitoring radiofrequency ablation catheter

Registration Classification: Class III Active Medical Devices

Registration Certificate No. National Armament Note 20253010446

The product is used in medical institutions and is similar to that of cardiac radiofrequency eliminated by Shanghai Hongtong Industrial Co., Ltd

The Rongyi (model: RFG-CF2, software release V1) can be used for drugs when used in conjunction with the instrument

Intended Use Treatment of refractory recurrent symptomatic persistent atrial fibrillation. Produced with Shanghai Hongtong Industrial Co., Ltd

3D Cardiac Electrophysiology Mapping System (Model: HT-9000Pro, Software Release Version V2)

When used in conjunction with the cardiac information, it provides information about the location of the catheter 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 electrobiology, continuously meeting diversified clinical needs, and further enhancing the company's core competitiveness

Force.

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

February 27, 2025