Shanghai Huizhong Medical Technology Co., Ltd.（上海惠中医疗科技有限公司） - Leading Chinese IVD Manufacturer for

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Company Profile (Updated April 2026)

Shanghai Huizhong Medical Technology Co., Ltd. is a leADINg Chinese in vitro diagnostics (IVD) company dedicated to the research, development, manufacturing, and sales of diagnostic equipment and supporting reagents. Founded on February 14, 2008 and headquartered in Jinshan District, Shanghai, China, the company operates as a wholly-owned subsidiary of Hangzhou Huizhong Diagnostics Technology Co., Ltd. and is ultimately 100% penetratively held by Shanghai Runda Medical Technology Co., Ltd. (SSE: 603108), a publicly listed integrated medical laboratory service provider in china.

With approximately 100-199 employees (105 insured employees in 2024) and registered capital of RMB 150 million, Huizhong has established itself as a specialized manufacturer in the IVD industry. The company reported RMB 168.36 million in revenue for the first nine months of 2024, ACHieving a net profit of RMB 67.73 million during the same period, demonstrating strong profitability with healthy margins.

2025 FDA Milestone:
On June 18, 2025, Shanghai Huizhong Medical's Glycated Hemoglobin Test System (Model MQ-3000/MQ-3000PT) received FDA 510(k) substantial equivalence determination (K242911), being deemed substantially equivalent to the predicate device Bio-Rad D-100 HbA1c System. This landmark achievement marks the first Chinese HbA1c detection device to reach international regulatory compliance standards, providing a critical case study for domestic IVD products entering the US market. The system utilizes ion-exchange high-performance liquid chromatography (HPLC) technology to quantitatively measure HbA1c in human whole blood, with results traceAble to DCCT reference methods and IFCC standards through NGSP certification.

Corporate History & Ownership Structure

Founded: February 14, 2008
Registered Address: No. 1018 Weichang Road, Shanyang Town, Jinshan District, Shanghai, China
Legal Representative: Liu Hui
Company Type: Limited Liability Company (Wholly Owned by Legal Person)
Registered Capital: RMB 150 million
Employees: 100-199 (105 insured employees in 2024)
2024 Jan-Sep Revenue: RMB 168.36 million
2024 Jan-Sep Net Profit: RMB 67.73 million
Parent Company: Hangzhou Huizhong Diagnostics Technology Co., Ltd. (100% shareholder)
Ultimate Parent: Shanghai Runda Medical Technology Co., Ltd. (SSE: 603108, 100% penetrative holding)

Key Milestones:

- 2008: Company established in Shanghai Jinshan District, beginning IVD equipment development

- 2017-2021: Consecutively awarded A-level Taxpayer status by Chinese tax authorities for four years

- 2019: MQ-2000PT glycated hemoglobin analyzer successfully installed in Thai hospital, marking expansion into Southeast Asian markets

- 2023: Completed equity restructuring and executive filing adjustments; recognized as High-Tech Enterprise with 15% preferential tax rate (valid through 2025)

- 2024: Launched new MH-60 and MH-120 five-part differential hematology analyzers; MQ-6000 glycated hemoglobin analyzer added to product portfolio

- 2025: Awarded Shanghai Specialized and Innovative SME and Jinshan District Technology Little Giant Enterprise; received FDA 510(k) substantial equivalence for MQ-3000 HbA1c system (K242911)

Revolutionary Product Portfolio

Glycated Hemoglobin (HbA1c) Analysis Systems

Huizhong's flagship product line for diabetes management:

- MQ-3000/MQ-3000PT: Advanced HPLC-based glycated hemoglobin analyzer with FDA 510(k) clearance (2025); detection range 3.0%-15.0% (NGSP) or 9.3-140.5 mmol/mol (IFCC); uses ion-exchange HPLC with 415nm absorbance detection

- MQ-6000: New generation glycated hemoglobin analyzer added to the product line in 2024

- MQ-8000: Latest generation glycated hemoglobin analysis system

- MQ-2000PT: Earlier generation HPLC glycated hemoglobin analyzer successfully deployed in Thailand and exported to multiple countries across Europe, Asia, and Africa

Hematology Systems

- MH-60: Five-part differential hematology analyzer launched in 2024

- MH-120: Advanced five-part differential hematology analyzer launched in 2024; designed for seamless integration with MQ-8000 glycated hemoglobin analyzer to build fully automated intelligent testing lines

- DX-100 Series Automatic Blood Cell Analyzer: Complete blood count (CBC) analysis system

Blood Gas Analysis Systems

- MB-3100 Series Blood Gas Analyzer: Automated blood gas analysis system for critical care and emergency diagnostics

- EB Series Supporting Electrodes: Dedicated electrodes for blood gas analyzers

Chemiluminescence Immunoassay (CLIA)

- Tube-Type Semi-Automatic Chemiluminescence Immunoassay Analyzer: Compact immunoassay system for hormone, tumor marker, and infectious disease testing

POCT Solutions

- Med-Q POCT Management Platform: Integrated point-of-care testing management system for hospital and clinical settings

- Blood Glucose Meters: POCT blood glucose monitoring devices

Technological Innovation & R&D Capabilities

Intellectual Property: The company holds 45 trademarks and 70 patents (per Baidu Baike), with Patsnap databases recording approximately 60 active patents covering diagnostic instrumentation, sample handling systems, and analytical methods.

Research Focus: Huizhong maintains active R&D in chemiluminescence analyzer feeder systems, blood gas electrode technology, and HPLC chromatography optimization. Published research in China Instrumentation (2023) detailed innovative structural designs for high-capacity, compact chemiluminescence analyzer sample rack systems.

Manufacturing Standards: All production facilities located in Shanghai with strict quality control; products meet domestic and international regulatory requirements including NMPA (China), FDA (US), and CE standards for export markets.

Regulatory Achievements & Quality Standards

China NMPA: Multiple Class II and Class III medical device registrations for glycated hemoglobin analyzers, blood gas systems, and hematology instruments

US FDA: 510(k) substantial equivalence determination for MQ-3000/MQ-3000PT Glycated Hemoglobin Test System (K242911, June 2025); deemed substantially equivalent to Bio-Rad D-100 HbA1c System

International Certifications: Products exported to Europe, Asia, and Africa with relevant market registrations (including Thailand FDA registration)

Corporate Honors:

- Shanghai Specialized and Innovative SME (2025)

- Jinshan District Technology Little Giant Enterprise (2025)

- High-Tech Enterprise certification (15% preferential tax rate, valid 2023-2025)

- A-level Taxpayer (2017, 2018, 2019, 2021)

Global Market Presence

Domestic Market (China): Strong presence in Shanghai and nationwide through parent company Runda Medical's extensive distribution network; products deployed in tertiary hospitals, clinical laboratories, and primary care institutions

International Markets: Products exported to multiple countries including:

- Southeast Asia: Thailand (MQ-2000PT installed in hospitals since 2019)

- Europe: Glycated hemoglobin systems exported to European markets

- Africa: Diagnostic equipment exported to African countries

Export Strategy: Leveraging Runda Medical's international department (international@rundamedical.com) for global market expansion

Subsidiaries & Investments

Shanghai Yicheng Precision Machinery Co., Ltd. (上海益骋精密机械有限公司): Wholly-owned subsidiary (100% equity) responsible for precision mechanical components manufacturing to support Huizhong's diagnostic instrument production.

2026 Outlook & Strategic Vision

US Market Entry: Following FDA 510(k) clearance for MQ-3000, accelerating US market commercialization efforts for glycated hemoglobin analyzers, targeting clinical laboratories and diabetes care centers.

Product Pipeline: Continued development of next-generation HPLC systems, expansion of hematology analyzer portfolio (MH-60/MH-120 series), and advancement of POCT management platform capabilities.

Intelligent Testing Lines: Promoting MH-120 hematology analyzer integration with MQ-8000 glycated hemoglobin analyzer to build fully automated intelligent testing lines for clinical laboratories.

International Expansion: Building on Thailand and European market presence to expand into additional Southeast Asian, Middle Eastern, and Latin American markets.

Technology Upgrades: Enhancing automation, connectivity, and AI-assisted diagnostic capabilities across product lines to meet evolving clinical laboratory needs.

Manufacturing Scale-Up: Leveraging Jinshan District production facilities and Yicheng Precision Machinery subsidiary to increase capacity and maintain cost competitiveness.

Contact Information

Headquarters

Company: Shanghai Huizhong Medical Technology Co., Ltd.
Address: No. 1018 Weichang Road, Shanyang Town, Jinshan District, Shanghai 201512, China
Phone: +86 21-64186268
Parent Company Website: www.rundamedical.com
International Contact: international@rundamedical.com

Key Personnel

Legal Representative: Liu Hui
Ultimate Parent Company (Runda Medical): Listed on Shanghai Stock Exchange (SSE: 603108)

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