Company Profile
Beijing Shuimu Jiheng Biotechnology Co., Ltd. is a China-based manufacturer of in-vitro diagnostic standards and quality control products, headquartered at 3rd Floor, Building 15, No. 15 Jingsheng South 4th Street, Tongzhou District, Beijing, China. Founded on December 23, 2020 and led by Legal Representative Wang Jun, the company operates as a wholly owned subsidiary of Beijing Zhongguancun Shuimu Medical Technology Co., Ltd., serving clinical laboratories, IVD manufacturers and healthcare institutions across China. The company also maintains a Suzhou subsidiary for expanded R＆D and production capacity.
Core Products ＆ Technologies
IVD Quality Control Products
• Immunoassay Multi-Analyte QC: Third-party quality control product for tumor markers, thyroid hormones and other immunoassay analytes, registered under NMPA (京械注准20222400342, August 2022)
• Clinical Chemistry Multi-Analyte QC: Third-party quality control product for liver function, renal function, cardiac markers and routine chemistry panels, registered under NMPA (京械注准20222400338, August 2022)
• Urinalysis Biochemistry QC: Urine biochemistry quality control product for quantitative urine analyte testing, registered under NMPA (京械注准20242400360, 2024)
• Coagulation QC: Multi-item composite coagulation quality control products for PT, APTT, fibrinogen and D-dimer assays, with patent application for preparation methodology (CN117741166A, March 2024)
Reference Materials ＆ Standards
• National Secondary Reference Material (ALT): Freeze-dried human serum reference material for alanine aminotransferase, certified by the State Administration for Market Regulation in 2023 (Certificate No. GBW(E)091247)
• 25-Hydroxyvitamin D3 Reference Material: Certified reference material for vitamin D testing accuracy and standardization (Certificate No. GBW(E)091223)
• Custom Reference Materials: Tailored reference materials and performance verification panels for IVD manufacturers and clinical laboratories
CDMO ＆ Technical Services
• IVD CDMO Services: Contract development and manufacturing for calibration materials, quality control products and reference panels
• ISO 15189 Consulting: Laboratory quality management system consulting and accreditation support services
• Indoor QC Information System: Quality control information management software for laboratory statistical process control
Market Position ＆ Certifications
Beijing Shuimu Jiheng Biotechnology holds a specialized position in the Chinese IVD quality control and reference materials market, competing with Bio-Rad Laboratories, Randox Laboratories and Thermo Fisher Scientific in the third-party QC segment. Key strengths include:
• 5+ years of focused R＆D heritage in IVD standards and quality control innovation
• Patent portfolio: Invention patent granted in 2024 for anti-epileptic drug concentration QC methodology; patent application filed in 2024 for multi-item composite coagulation QC preparation
• Regulatory compliance: Class II medical device registrations (NMPA); Class I medical device production license (京经药监械生产备20240009号, September 2025); national secondary reference material certificates
• Industry recognition: 2022 Beijing Science and Technology Award First Prize; 2024 National High-Tech Enterprise certification; 2024 Technology-Based SME designation
• Market engagement: Active participation in national and provincial EQA program bidding, including 2026 Liaoning Province clinical laboratory EQA material procurement
Corporate Timeline
2020 — Founded in Beijing by senior IVD industry professionals as a subsidiary of Zhongguancun Shuimu Medical
2021 — Establishes Suzhou subsidiary (苏州水木济衡生物技术有限公司) for dual-core R＆D and production expansion
2022 — Receives NMPA Class II medical device registration for immunoassay and clinical chemistry multi-analyte QC products
2023 — Freeze-dried human serum ALT reference material approved as national secondary standard substance (GBW(E)091247)
2024 — Granted invention patent for anti-epileptic drug concentration QC products; certified as National High-Tech Enterprise and Technology-Based SME; receives NMPA registration for urinalysis biochemistry QC product
2025 — Obtains Class I medical device production license for in-vitro diagnostic reagents (京经药监械生产备20240009号)
2026 — Selected as supplier for Liaoning Province clinical laboratory EQA program (March 2026)
Target Markets ＆ Applications
• Clinical Laboratory Quality Management: Third-party IQC and EQA materials for hospital laboratories, independent testing centers and blood banks
• IVD Product Development: Reference panels, calibration materials and performance verification kits for IVD manufacturers during R＆D and registration
• Laboratory Accreditation: ISO 15189 consulting and quality management software for laboratory standardization and result inter-laboratory comparability
• Custom Manufacturing: CDMO services for IVD companies requiring specialized control materials, calibrators and reference standards
Contact Information
Global Headquarters
Registered Address: 3rd Floor, Building 15, No. 15 Jingsheng South 4th Street, Tongzhou District, Beijing, China
Production Address: 3rd Floor North Wing ＆ Room 101 Southeast Corner, 1st Floor, Building 1, No. 10 Boxing 5th Road, Beijing Economic-Technological Development Area, China
Suzhou R＆D Center
Address: No. 59 Weixin Road, Suzhou Industrial Park, Jiangsu, China (Suzhou Shuimu Jiheng Biotechnology Co., Ltd.)
Parent Company
Beijing Zhongguancun Shuimu Medical Technology Co., Ltd.
Website: zgcsm.cn
Corporate Online Presence
Website: smjh-bio.com
Email: smjh-sales@zgcsm.cn
Phone: 010-59771556
