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 in Jinhua, Zhejiang Province, Xinke Medical has grown into a leading manufacturer of in vitro diagnostic reagents in China. With ISO 9001 and ISO 13485 certifications, we serve healthcare institutions worldwide with high-quality, cost-effective reagent solutions.
Our product portfolio covers 15 major categories of IVD reagents, compatible with analyzers from Beckman, Sysmex, Roche, Abbott, Siemens, Mindray, and other major brands. We focus on providing reliable, affordable solutions for primary healthcare institutions, emergency departments, and community medical centers.
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
- Founded at No. 1851 Huancheng South Road, Jinhua, Zhejiang
- Certified for medical device quality management system
- Relocated to No. 518 Huatai Road
- Named a Zhejiang Science & Technology SME
- Xinke Party branch established
- Work Safety Standardization Level III certified
- Class II medical device production license granted
- Moved to current HQ at No. 133 Lengshui Road, Jinpan Development Zone
- Recognized as a National High-Tech Enterprise
- Own brand “XKIVD” registered
- Honored as a Top 100 Taxpayer
- Upgraded and renamed “Zhejiang Xinke Medical”
- Named a Zhejiang Innovative SME
- Ranked Top 10 industrial enterprise for per-mu tax
- Hangzhou office opened
- Named a Zhejiang “Specialized & Sophisticated” SME
- Zhejiang Credit Management Demonstration Enterprise
- Subsidiary Hangzhou Xinke founded
- Named a Jinhua Municipal Green Factory
- 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
- Vice-president unit, Pan’an County Pharmaceutical Association
Scroll down to journey through our history
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 Innovative SME
Zhejiang Innovative SME, accredited by Zhejiang Provincial Department of Economy & Information Technology.
Zhejiang Technology-based SME
Zhejiang Technology-based SME, accredited by Zhejiang Provincial Department of Science & 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 Taxpayer per Mu 2025
Top Taxpayer per Mu 2025, honored by local government for high land-use efficiency and profitability.
Top 100 Taxpayers 2025
Top 100 Taxpayers 2025, honored by local tax authority for lawful and honest tax payment.
Quality Management System (ISO 9001)
Quality Management System (ISO 9001), CNAS-accredited and internationally recognized, No. 04723Q10667RSM.
Medical Device Quality Management (ISO 13485)
Medical Device Quality Management, GB/T 42061-2022 idt ISO 13485:2016, certificate No. 04723Q10000667.
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.
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.
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.
Five-Star Party Organization
Five-star rating of grassroots Party organization, reflecting party building at the enterprise.
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.
Medical Device Production License
Medical Device Production License (original, renewed 2026), No. 浙药监械生产许20170011号, covering Class II: 6840 IVD reagents, valid until 2031.
Class I Medical Device Filing
Class I Medical Device Production Filing, covering 6840 IVD reagents and sample processing reagents.
Consumer-Trust Unit of "Satisfactory Consumption in Yangtze River Delta"
Consumer-Trust Unit of the "Satisfactory Consumption in Yangtze River Delta" initiative (annual evaluation).
一种试剂搅拌装置
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一种试剂灌装台
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一种用于试剂容器的收纳装置
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一种血细胞分析仪用清洗液清洗率的收集样品装置
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1一种在线检测的电导率测定仪装置
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一种隔绝空气取样装置
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一种带有支架的电动搅拌器
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一种反应釜的固定支架
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一种重结晶沥干架
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一种血细胞分析仪用清洗液清洗率测定方法
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一种试剂瓶
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一种实验室离子型废液处理装置
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1一种发光缓冲液航盖
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一种瓦楞纸箱纸板承重性能测定装置
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一种瓦楞纸箱纸板戳穿强度测定装置
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一种清洗液试剂瓶封口装置 (2)
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一种血液分析仪试剂瓶瓶托
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一种自动灌装机用防滴漏加料管
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一种贴标机用多功能传送带
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一种投料口用漏斗装置
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一种全自动软桶封口旋盖灌装一体机
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一种重结晶用沥干架
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全自动直列常压灌装机防碰撞保护装置
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一种罗氏Cobase801化学发光免疫分析仪配套用三丙胺缓冲液及其制备方法
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一种血细胞分析仪用多规格适配器
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一种高性能生化清洗液及其制备方法
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一种液体罐装头
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一种铝箔软袋罐装设备用罐装头
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一种全自动塑料试管封口修边装置
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一种防止灌装过程中撞针的装置
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一种PE膜封口瓶盖
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一种具有加热封边结构的分切机下压装置
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自动投料机
专利证书
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 90+ countries and regions, serving hospitals, laboratories and distributors.
Asia Pacific
Philippines, Vietnam, Myanmar, Bangladesh, New Zealand
Middle East
Iraq, Iran, Yemen, Bahrain, Syria
Africa
Nigeria, Ghana, Sudan, Tanzania, Uganda, South Africa
Americas
Brazil, Venezuela, Honduras, El Salvador
Work With Us
Whether you are a hospital, laboratory, or distributor, we look forward to partnering with you