Securities code: 688617 Securities abbreviation: Huitai Medical Announcement No.: 2025-008

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 March 3, 2025, Shenzhen Huitai Medical Device Co., Ltd. (hereinafter referred to as the "Company") was fully established

Hunan Epte Medical Device Co., Ltd., a subsidiary of Hunan Epte, has obtained a medical device registration certificate, the details are as follows:

1. The specific situation of the medical device registration certificate

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

Product Name: Vena Cava Filter System

Registration Classification: Class III Passive Medical Devices

Registration certificate number National Machinery Note 20253130465

The product is inserted percutaneously via a transfemoral or transjugular approach for the prevention of the inferior vena cava

Pulmonary embolism (PE) caused by the detachment of systemic emboli. Include:

1. Symptomatic pulmonary embolism or acute thrombosis of the inferior vena cava and iliac, femoral and popliteal veins has occurred

Adult patients have one of the following conditions:

(1) Those with contraindications to anticoagulation therapy;

Intended use: (2) Complications such as bleeding during anticoagulation therapy;

(3) Patients with recurrent pulmonary embolism after adequate anticoagulation therapy and those who cannot achieve adequate anticoagulation for various reasons.

2. Patients with symptomatic pulmonary embolism and acute deep vein thrombosis of the lower limbs.

3. There are free floating thrombis or a large number of acute thrombosis in the iliac, femoral vein or inferior vena cava.

4. Those who have been diagnosed with thrombophilia and have recurrent pulmonary embolism.

5. Acute deep vein thrombosis of the lower extremities, and transcatheter contact thrombolysis therapy and percutaneous machinery are to be performed

Patients who have undergone sexual thrombectomy (PMT).

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 peripheral field, 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

March 5, 2025