Scivita Medical Testing Center Achieves CNAS Accreditation: Full-Chain Endoscope Testing Sets New Industry Benchmark

Scivita Medical Testing Center Achieves CNAS Accreditation: Full-Chain Endoscope Testing Sets New Industry Benchmark

Scivita Medical's testing center has received official laboratory accreditation from the China National Accreditation Service for Conformity Assessment (CNAS), under Accreditation Number CNAS L23642.

This accreditation, granted to a leader in innovative endoscope technology, validates Scivita Medical's full-chain testing capabilities for rigid and electronic endoscopes against the highest international standards. It provides comprehensive technical support across the entire product life cycle for endoscope and related equipment R&D, solidifying Scivita Medical's technical influence in the global endoscope industry and marking a shift for domestic endoscopes from technological catch-up to standard-setting.

It is noteworthy that CNAS national laboratory accreditation represents the highest level of domestic laboratory capability in China, with its assessment standards strictly adhering to the ISO/IEC 17025 international guidelines. Within the highly specialized field of medical endoscopes, companies possessing full-chain testing capabilities that meet CNAS standards and achieve certification are exceptionally rare nationwide.

Following a 12-month intensive effort, Scivita Medical's testing center has secured accreditation for 33 core capabilities, comprehensively covering all critical dimensions of endoscope technology, including:

1、Rigid Endoscopes Optical Testing: Field of view and viewing angle, color fidelity, luminous efficiency of light guide assemblies, etc.

2、Electronic Endoscopes Imaging Testing: Luminance response characteristics, signal-to-noise ratio (SNR), spatial frequency response, static image dynamic range, etc.

3、Cold Light Source Testing: CRI(Ra), infrared cut-off performance, etc.

4、Electrical Safety Testing: Luminance response characteristics, earth continuity resistance, etc.

5、Medical electrical safety testing: Leakage current, dielectric strength, protective earth resistance, etc.

"The CNAS accreditation is a dual endorsement of the laboratory's technical capabilities and standardized operations," stated the head of Scivita Medical's testing center. "It strengthens our underlying product quality assurance and provides a foundation of standardized trust for international cooperation. The testing center will continue to optimize its capabilities to support the R&D efficiency and compliance process of our innovative products."

Beyond the capabilities listed above, the center also houses specialized laboratories for physical performance, electromagnetic compatibility (EMC), aging, and reprocessing validation, providing dual assurance for both full product lifecycle reliability and clinical safety. Furthermore, the testing center has established core testing capabilities aligned with FDA 510(k) and EU MDR registration requirements.

Scivita Medical Aging Laboratory

Following accreditation, test reports issued within its scope will be recognized by the signatories of the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC-MRA)—over 100 economies worldwide. This significantly enhances the international credibility of Scivita Medical's test results and marks the successful establishment of its full-chain "R&D - Testing - Global Registration" closed-loop capability, further strengthening Scivita Medical's core competitiveness as a global innovative medical device enterprise.

About Scivita Medical

Founded in 2016, Scivita Medical is a medical device company that provides minimally invasive diagnosis and treatment solutions, and focuses on research, development and commercialization of medical endoscopes and related products. Scivita Medical takes ‘Globalization’ as its core strategy and has established R&D centers both in China and Japan. With solid in-house R&D capabilities, Scivita Medical has established a unique technology platform built upon five synergistic core technologies, and built a comprehensive portfolio of endoscope products and therapeutic products covering all types of endoscope procedures conducted by the various clinical departments, to address diverse medical needs. Adhering to its value of ‘Clinical Focus’ ‘Collaborative Innovation’ ‘People Oriented’ ‘Excellence & Efficiency’, Scivita Medical will continuously upgrade its core technologies, improve market penetration with excellent products aiming to become the preferred brand, trusted by doctors and patients around the world.

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