National High-Tech Enterprise
A national high-tech enterprise specializing in IVD reagents since 2004
Years of Experience
Reagent Products
Countries & Regions
Compatible Analyzers
Our Story
Founded in 2004, Zhejiang Xinke Medical Technology Co., Ltd. has always upheld the spirit of innovation and the pursuit of excellence, dedicated to providing quality products and services to customers worldwide.
The company specializes in in vitro diagnostic (IVD) reagents, with unique technical advantages in niche segments such as cleaning solutions for clinical analyzers, universal buffers for chemiluminescence immunoassay analyzers, and reagents for hematology analyzers. To date, it has obtained more than 30 invention and utility model patents, including "Method for Measuring the Cleaning Rate of Cleaning Solutions for Hematology Analyzers" and "Tripropylamine Cleaning Buffer for Roche Cobas e801 Chemiluminescence Immunoassay Analyzers and Its Preparation Method", and participated in drafting the industry standard YY/T 0456 "Reagents for Hematology Analyzers". Backed by years of accumulated technical expertise, the company stands out in these niche segments and holds a leading position in the industry.
The company has built a mature and efficient R&D team of more than 40 professionals holding master's degrees or intermediate/senior professional titles. Its high-tech R&D center houses a 1,500 m² central laboratory equipped with clinical analyzers from Roche, Abbott, Beckman and Siemens, along with 200+ advanced analytical instruments from home and abroad, including atomic absorption, gas and liquid chromatography systems, making it a collaboration partner and teaching internship base for Zhejiang Normal University, Zhejiang University of Technology, Jinhua Polytechnic and other universities and research institutes.
Since 2008, the company has continuously passed ISO 9001 and ISO 13485 quality management system certifications. In technological innovation, it has earned honors such as Jinhua Municipal Science & Technology R&D Center, Zhejiang Science & Technology SME, Zhejiang Innovative SME, Zhejiang "Specialized & Sophisticated" SME and National High-Tech Enterprise, staying firmly on the specialized and sophisticated path; in business integrity, it keeps strengthening corporate credit management and building a trustworthy, compliant corporate image, earning recognition from government authorities and users, and was rated a Zhejiang Credit Management Demonstration Enterprise.
The company operates a 2,000 m² cleanroom workshop with 11 fully automatic filling lines and 60+ advanced production units such as 6.0 t/h reverse osmosis + EDI ultrapure water systems, delivering a daily capacity of up to 80 tons. Stable production conditions and standardized quality management have made it the preferred OEM partner for cleaning solutions of many clinical analyzer manufacturers.
Corporate Culture
Growing with Xinke, growing together
Integrity
Integrity is the foundation of who we are and the first principle of every action. With customers it means putting them first and never promising what we cannot deliver; with employees it means honesty and candour, plus responsibility and loyalty to the company.
Customer First
Customers come first — we work consistently for their success. We stay enthusiastic about customers, deliver the products and services they need, keep every promise, and anticipate their future needs.
Professionalism
Professionalism means building vocational expertise through learning, training and development, so we can serve customers with specialist knowledge and shape a professional company image.
Learning
Learning is a virtue. We learn from the successes of leading companies and stay open to feedback. We treat knowledge as our most valuable resource, fostering a culture of sharing and growth that lifts the whole organisation.
Milestones
Two decades of innovation and growth
- 20042004
- Founded at No. 1851 Huancheng South Road, Jinhua, Zhejiang
- 20092009
- Relocated to No. 518 Huatai Road
- Certified for medical device quality management system
- 20162016
- Named a Zhejiang Science & Technology SME
- 20172017
- Xinke Party branch established
- Work Safety Standardization Level III certified
- 20192019
- Moved to current HQ at No. 133 Lengshui Road, Jinpan Development Zone
- 20202020
- Recognized as a National High-Tech Enterprise
- Own brand “XKIVD” registered
- 20212021
- Honored as a Top 100 Taxpayer
- 20222022
- Named a Zhejiang Innovative SME
- Ranked Top 10 industrial enterprise for per-mu tax
- Hangzhou office opened
- 20232023
- Named a Zhejiang “Specialized & Sophisticated” SME
- Zhejiang Credit Management Demonstration Enterprise
- Subsidiary Hangzhou Xinke founded
- 20242024
- Named a Jinhua Municipal Green Factory
- 20252025
- Re-ranked Top 10 per-mu tax and Top 100 Taxpayer
- Named a Key TCM & Health Enterprise
- Standing council member, Jinhua High-Tech Enterprise Association
- Vice-president unit, Jinhua Medical Devices Association
- Five-Star Grassroots Party Organization
- 20262026
- Vice-president unit, Pan’an County Pharmaceutical Association
Certifications
Official honors and quality management certificates — click to view full size
National High-Tech Enterprise
National High-Tech Enterprise, recognizing sustained R&D investment and commercialization in IVD reagents.
Zhejiang Credit Management Demonstration Enterprise
Zhejiang Credit Management Demonstration Enterprise, reflecting sound credit management and good reputation.
Zhejiang Specialized & Innovative SME
Zhejiang Specialized & Innovative SME, focused on the IVD niche with specialization, refinement and innovation.
Zhejiang Technology-based SME
Zhejiang Technology-based SME, accredited by Zhejiang Provincial Department of Science & Technology.
Zhejiang Innovative SME
Zhejiang Innovative SME, accredited by Zhejiang Provincial Department of Economy & Information Technology.
Jinhua Science & Technology R&D Center
Jinhua In-vitro Diagnostic Reagent Science & Technology R&D Center, accredited by Jinhua Science & Technology Bureau.
Key Enterprise of TCM Health Industry
Key Enterprise of TCM Health Industry, serving R&D support for TCM and health industry.
Top 100 Taxpayers 2025
Top 100 Taxpayers 2025, honored by local tax authority for lawful and honest tax payment.
Top Taxpayer per Mu 2025
Top Taxpayer per Mu 2025, honored by local government for high land-use efficiency and profitability.
Vice President of Industry Association
Serving as vice president of the industry association, contributing to industry standards and ecosystem.
Executive Council Member
Executive council member of the industry association.
Five-Star Party Organization
Five-star rating of grassroots Party organization, reflecting party building at the enterprise.
Consumer-Trust Unit of "Satisfactory Consumption in Yangtze River Delta"
Consumer-Trust Unit of the "Satisfactory Consumption in Yangtze River Delta" initiative (annual evaluation).
Made-in-China.com Verified Supplier
Made-in-China.com Verified Supplier, audited on-site by Bureau Veritas (report MIC-ASI183545, 2018-05-31).
Alibaba Verified Supplier
Alibaba.com certified supplier qualification.
Medical Device Quality Management (ISO 13485)
Medical Device Quality Management, GB/T 42061-2022 idt ISO 13485:2016, certificate No. 04723Q10000667.
Quality Management System (ISO 9001)
Quality Management System (ISO 9001), CNAS-accredited and internationally recognized, No. 04723Q10667RSM.
CE DoC (Hematology Analysis Staining Solution)
IVDR
CE Declaration of Conformity for Hematology Analysis Staining Solution under IVDR (EU) 2017/746, Class A, June 2024.
CE DoC (Hematology Analysis Lytic Agent)
IVDR
CE Declaration of Conformity for Hematology Analysis Lytic Agent under IVDR (EU) 2017/746, Class A, June 2024.
CE DoC (Cleaning Solution)
IVDR
CE Declaration of Conformity for Cleaning Solutions under IVDR (EU) 2017/746, Class A, covering all models (see annex).
CE DoC (Buffer)
IVDR
CE Declaration of Conformity for Buffer under IVDR (EU) 2017/746, Class A, June 2024.
CE DoC (Hematology Analysis Diluent)
IVDR
Issued under the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, Class A, EMDN code W0699, June 2024.
Patent Wall
Professional Team
Xinke Medical has a professional team of senior engineers, quality management experts, and technical service personnel. We continue to invest in R&D and establish partnerships with universities and research institutes to ensure continuous innovation in product technology.
Global Presence
Our products are exported to 150+ countries and regions, serving hospitals, laboratories and distributors.
Work With Us
Whether you are a hospital, laboratory, or distributor, we look forward to partnering with you