Shandong Xinhua Medical Equipment Co., Ltd. Announcement on Subsidiary Products Obtaining Class II Medical Device Registration Certificates

The board of directors of the Company and all its directors warrant that the contents of this announcement contain no false representations, misleading statements, or material omissions, and assume individual and joint liability for the authenticity, accuracy, and completeness of the contents.

Subsidiary of Shandong Xinhua Medical Instruments Co., Ltd. (hereinafter referred to as the “Company” or “Xinhua Medical”), Xinhua Medical Rehabilitation Industry (Xi’an) Co., Ltd. has recently received the “Medical Device Registration Certificate of the People’s Republic of China” issued by the Shaanxi Provincial Drug Administration. The specific details are as follows:

I. Specific details of the medical device registration certificate

1. Product name: Transcranial magnetic stimulation device

2. Registration certificate number: Shaanxi Device Approval (2026) 2090030

3. Name of registrant: Xinhua Medical Rehabilitation Industry (Xi’an) Co., Ltd.

4. Address of registrant: No. 99 Gongwu Avenue, International Port Area, Xi’an City, Shaanxi Province, Building F, Unit 1901, China’s Central and Western Region Port Logistics Financial Town

5. Manufacturing address: Logistics Center, Building 2, Warehouse 2, Unit 3-B, 2nd Floor, Anbo Xi’an International Port Area, No. 579 Gongxing Fourth Road, International Port Area, Xi’an City, Shaanxi Province

6. Structure and components: The product consists of a power module, control module, discharge capacitor, magnetic stimulation module, cooling module, touch integrated machine, stimulation coil, transcranial magnetic stimulation device software (release version number V1), motor evoked potential module (including electrode wires, optional), positioning cap (optional), cart and coil bracket.

7. Models and specifications: MT7110-60A, MT7110-80A, MT7110-100A, MT7124-60A, MT7124-80A, MT7124-100A

8. Indications: By stimulating the human central nervous system and peripheral nerves, for electrophysiological examination of the human central nervous system and peripheral nerves and motor nerve function assessment, as well as for adjunctive treatment or improvement of insomnia symptoms (not for insomnia caused by anxiety or depression). For adjunctive treatment of brain nerve and nerve injury-related diseases.

9. Approval date: 2026-03-26

10. Valid until: 2031-03-25

11. Related information for comparable products: According to data obtained from the official website of the National Medical Products Administration, as of now, 64 companies in the domestic industry have obtained medical device registration certificates for comparable products.

12. Main features of the product

The transcranial magnetic stimulation device product integrates point-accurate stimulation, includes a positioning cap and motor evoked potential (MEP) as standard for threshold calibration, supports target localization, and improves operational efficiency and accuracy of individualized stimulation dosage; magnetic field strength and frequency are adjustable across a wide range to meet needs in multiple scenarios; it is equipped with a 3D stereoscopic brain region map, which is intuitive and easy to use, and supports personalized方案 and data management; it integrates triple real-time monitoring and protection of temperature, voltage, and current to ensure the equipment operates within safe limits, avoiding risks of overheating or overvoltage; it uses an intelligent liquid-cooled temperature control system with dynamic liquid-cooled circulation adjustment, enabling the device to work efficiently, stably, and for long durations.

II. Impact of obtaining the above medical device registration certificate on the Company’s performance

The approval for listing and marketing of the transcranial magnetic stimulation device registration certificate will help enrich and improve the Company’s rehabilitation product line, provide customers with multiple options, and is conducive to enhancing the Company’s core competitiveness.

III. Risk disclosure

After the product is launched, actual sales performance depends on the effectiveness of future market promotion. At present, it is still not possible to predict the specific impact of the above product on the Company’s future operating performance. Investors are kindly reminded to be mindful of investment risks.

This announcement is hereby issued.

Board of Directors of Shandong Xinhua Medical Instruments Co., Ltd.

April 4, 2026

Securities code: 600587 Securities abbreviation: Xinhua Medical Announcement No.: Lin 2026-014

Announcement of Shandong Xinhua Medical Instruments Co., Ltd. regarding its subsidiary product obtaining a Class II medical device registration certificate

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