Securities code: 688617 Securities abbreviation: Huitai Medical Announcement No.: 2024-062

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.

Recently, Shenzhen Huitai Medical Equipment Co., Ltd. (hereinafter referred to as the "Company") obtained a medical treatment

Device registration certificate, a wholly-owned subsidiary, Shanghai Hongtong Industrial Co., Ltd. (hereinafter referred to as "Shanghai Hongtong") has obtained a medical device registration certificate and a medical device change registration document, the details are as follows:

1. The specific situation of the medical device registration certificate

(1) The basic information of the company to obtain the registration certificate

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

Product Name: Single-use cardiac pulsed electric field ablation catheter

Registration Classification: Class III Active Medical Devices

Registration certificate number National Machinery Note 20243012499

This product is used in medical institutions and is used in conjunction with Shanghai Hongtong's Heart Pulsed Electric Field Ablation Instrument (Model:

PFG-microl, software release version V1) needs to be used in conjunction with the company's wholly-owned subsidiary, Hunan Ai

Putt Medical Devices Co., Ltd. produces a single-use magnetoelectric positioning pressure monitoring pulsed electric field

Ablation catheters are used to treat drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

Intended Use

Among them, this product is used for pulmonary vein orifice and vestibular ablation, and one-time magnetoelectric positioning pressure monitoring pulse

Impulse field ablation catheters are used to supplement ablation. This product is generated with three-dimensional cardiac electricity produced by Shanghai Hongtong

When the mapping system (model: HT-9000Pro, software release version V2) is used

Electrophysiological mapping (stimulation and recording) is performed and information on the position of the catheter in the heart is provided.

(2) The basic information of Shanghai Hongtong to obtain the registration certificate

Name of registrant: Shanghai Hongtong Industrial Co., Ltd

Product Name: Cardiac Pulsed Electric Field Ablation Instrument

Registration Classification: Class III Active Medical Devices

Registration certificate number National Machinery Note 20243012477

The product is used in medical institutions and is used in the same place as the single-use heart pulsed electric field ablation produced by the company

catheter and the company's wholly-owned subsidiary, Hunan Epte Medical Equipment Co., Ltd., produced disposable makes

It is used in conjunction with a pulsed electric field ablation catheter for magnetoelectric positioning pressure monitoring for the treatment of drug refractory

Intended Use

sexual, recurrent, symptomatic, paroxysmal atrial fibrillation. One of them is a one-time cardiac pulsed electric field ablation

Catheters are used for pulmonary vein orifice and vestibular ablation, and pulsed electric fields are monitored using magnetoelectric positioning pressure on a single basis

Ablation catheters are used to supplement ablation. Please refer to the technical requirements of the product for the type of catheter used.

(3) The basic information of Shanghai Hongtong's change of registration certificate

Name of registrant: Shanghai Hongtong Industrial Co., Ltd

Product Name: Three-dimensional cardiac electrophysiology mapping system

Registration Classification: Class III Active Medical Devices

Registration certificate number National Machinery Note 20213070036

The product is used in medical institutions to send electrical stimulation signals and record the heart during cardiac electrophysiological surgery

Signal. When produced with the company/company's wholly-owned subsidiary, Hunan Epte Medical Equipment Co., Ltd

Intended Use

It can be displayed in real time when a magnetopositioning/magnetopositioning catheter is approved for use with this product

The position of the catheter and 3D modeling of 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 electrobiotechnology, 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 17, 2024