Suzhou Xinyitai Medical Equipment Co., Ltd.（苏州新亿泰医疗器械有限公司） - Medical Device Manufacturer in Taicang,

Key Milestones (2022–2026):
   Founded in December 2022 in Taicang, Suzhou. In March 2025, the balloon-type external counterpulsation device received NMPA registration approval (registration no. 国械注准20253090614). In April 2026, the NMPA issued a notice deregistering the balloon-type external counterpulsation device registration certificate (国械注准20253090614).

Company Profile (Updated April 2026)

Suzhou Xinyitai Medical Equipment Co., Ltd. (Chinese: 苏州新亿泰医疗器械有限公司) is a medical device manufacturing and trADINg company headquartered in Taicang, Suzhou, jiangsu Province, China. Established on December 6, 2022, the company operates as a limited liability company with natural person investment and is currently in active status.

The company is registered in the Taicang Xingyao Port (Star Medicine Port) biomedical industrial park in Shaxi Town, Taicang City, and has received local government support including biomedical industry development subsidies for new enterprises. The company maintains a small operational scale focused on medical device production and technology services.

Development History:

- 2022.12.06: Company founded in Taicang, Suzhou, with registered capital of RMB 5 million

- 2022: Received biomedical industry development special fund subsidy from Taicang City for new enterprise rental support

- 2025.03.24: Balloon-type external counterpulsation device received NMPA registration approval (registration no. 国械注准20253090614)

- 2026.04.17: NMPA issued notice deregistering the balloon-type external counterpulsation device registration certificate (国械注准20253090614)

Core Mission: To engage in the research, development, production, and sales of medical devices and related technologies, contributing to the biomedical industry in the Taicang-Suzhou region.

Core Products & Business Scope

Approved Product (Deregistered)

- Balloon-Type External Counterpulsation Device (气囊式体外反搏设备): Class III medical device; received NMPA registration in March 2025 (国械注准20253090614); deregistered in April 2026

Business Scope

- Licensed Projects: Class II medical device production; Class III medical device production; Class III medical device distribution

- General Projects: Class I medical device production and sales; Class II medical device sales; technical services, technology development, technology consulting, technology exchange, technology transfer, technology promotion; new material technology R&D; biochemical product technology R&D; software development; network technology services; network and information security software development; electronic product sales; lighting equipment sales; hardware retail; information system operation and maintenance services; information technology consulting services; casting mACHinery manufacturing; metal product sales; industrial engineering design services

Regulatory Information

- NMPA Registration: Balloon-type external counterpulsation device approved March 2025 (国械注准20253090614); deregistered April 2026

- Company Status: Active (存续)

Company Overview

Corporate Information

Legal Name (Chinese): 苏州新亿泰医疗器械有限公司

Legal Name (English): Suzhou Xinyitai Medical Equipment Co., Ltd.

Founded: December 6, 2022

Headquarters: Room 402, Building 7, No. 101 Zhaoxi Road, Shaxi Town, Taicang City, Suzhou, Jiangsu Province 215400, china

Registered Capital: RMB 5 million

Unified Social Credit Code: 91320585MAC5LP7001

Business Registration No.: 320585000697210

Legal Representative: Chen Yu (陈宇)

Company Type: Limited Liability Company (Natural Person Investment or Holding)

Industry: Medical Devices / Special Equipment Manufacturing

Social Insurance Contributors: 1 person

Website: Not availAble

Leadership

Legal Representative: Chen Yu (陈宇)

2026 Strategic Outlook

- Regulatory Compliance: Address the NMPA deregistration of the balloon-type external counterpulsation device and determine future product strategy

- Business Development: Continue operations within the approved business scope focusing on Class I and Class II medical device production and sales

- Local Industry Integration: Leverage presence in Taicang Xingyao Port biomedical industrial park for regional collaboration and growth

Contact Information

Company Address

Address: Room 402, Building 7, No. 101 Zhaoxi Road, Shaxi Town, Taicang City, Suzhou, Jiangsu Province, China

Postal Code: 215400

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