EPINTEK Guiyang Laboratory Achieves Major Expansion of National CMA Accreditation, Enabling Comprehensive "One-Stop" Testing Services for Medical Devices

GUIYANG, CHINA – EPINTEK's Guiyang Laboratory has successfully completed a significant expansion of its China Metrology Accreditation (CMA) scope and capabilities. This enhancement establishes full-spectrum testing services for most disposable medical consumables, encompassing physical, chemical, microbiological, biocompatibility, packaging, and animal testing – delivering true end-to-end solutions.

Enhanced Testing Capabilities:
The expanded accreditation covers biological evaluation, physics, chemistry, and microbiology. Key additions within biological evaluation include:

• In Vitro Mouse Embryo Test (IVMET)

  Quantification of Exogenous DNA Residue

  Animal Scald Model for Wound Healing Performance Evaluation

• Lymphocyte Proliferation Assay

• Cell Migration Assay

Extended Product Scope:
The CMA scope now comprehensively supports over 20 critical medical device categories, including:

• Medical Protective Equipment

• Hygiene Materials & Medical Textiles

• Anesthesia and Respiratory Circuits

• Vascular and Non-Vascular Catheters

• Advanced Dressings (e.g., Sodium Hyaluronate, Chitosan-based)

• Tissue Engineered Medical Products (incl. Animal-Derived Devices)

• Venous Indwelling Needles & Injection Needles

• Syringes, Infusion Sets, Blood Transfusion/Collection Sets

• Drainage, Suction, and Catheter Tubing Systems

• Ophthalmic Optical Devices

• Collagen-Based Hemostatic Sponges

• Drainage Catheters and Devices

• Endoscopic Surgical Instruments

• Puncture Devices & Dilators

• Orthopedic Surgical Instruments

• Gynecological and Obstetric Surgical Instruments

• Implantable Drug Delivery Systems

• Traditional Chinese Medicine Devices

• Surgical Procedure Kits & Delivery Systems

• Instruments for Use with Active Devices

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Commitment to Global Markets:
We invite industry partners to explore collaboration opportunities. Concurrently, EPINTEK is pursuing accreditation to key international standards, facilitating seamless market access for clients targeting global distribution.

About EPINTEK

EPINTEK, a medical device technology service platform supported by Guizhou Provincial Government investment, specializes in serving the rapidly advancing medical device and biopharmaceutical sectors. We provide integrated, one-stop solutions—including preclinical research, analytical testing, regulatory strategy & submissions, and clinical trial CRO services—to domestic and international manufacturers and research institutions.

Strategic Infrastructure:

• Operations Center: Hongqiao Business District, Shanghai

• Biomedical Laboratory: Wujiang District, Suzhou

• Electrical Medical & Wireless Comm. Lab: Suzhou Industrial Park

• Consumables Testing Center, OR Suite, Large Animal Center & South China Biomed R&D Hub: Baiyun District, Guiyang

• Orthopedic & Implantable Device Center: Hefei High-Tech Zone

  
  

Quality & Compliance:
EPINTEK operates one of China's few heavy-asset CRO laboratories, holding dual CNAS (ISO 17025) and CMA (China) accreditations, complemented by US-based A2LA (ISO 17025) and IAS accreditations. Our biology labs operate under FDA GLP-compliant systems. We deliver scientifically rigorous testing and research services accepted by regulatory authorities in China, the United States, and the European Union.

Contact EPINTEK:

• Tel: +86 21 5473 6833

• Testing Services: www.epintek.com

• Regulatory & Clinical Services: www.epintekservice.com

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