Securities code: 688617 Securities abbreviation: Huitai Medical Announcement No.: 2024-063

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 December 17, 2024, 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 magnetoelectric positioning pressure monitoring pulsed electric field ablation catheter

Registration Classification: Class III Active Medical Devices

Registration Certificate No. National Armament Note 20243012609

The product is used in medical institutions and is used with the heart pulse electric field of Shanghai Hongtong Industrial Co., Ltd

Rongyi (model: PFG-micro1, software release version V1) needs to be used in conjunction with the company

A single-use cardiac pulsed electric field ablation catheter is used in conjunction with a therapeutic refractory to medications

Intended use Recurrence, symptomatic paroxysmal atrial fibrillation. One of them is a one-time cardiac pulsed electric field ablation

The tube is used for pulmonary vein orifice and vestibular ablation, and this product is used for supplemental ablation. This product is the same as Shanghai Hongtong

Three-dimensional cardiac electrophysiology mapping system produced by Industrial Co., Ltd. (Model: HT-9000Pro, soft

V2) to provide 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 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

December 19, 2024