Resources

Access our certifications, technical documentation, and quality compliance information.

Quality Assurance

Our Certifications

Our factory holds international certifications, ensuring the highest quality standards in IVD manufacturing

ISO

ISO 13485

Factory Certified

Quality Management for Medical Devices

ISO 13485 certification ensures world-class quality management in our manufacturing facility.

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CE

CE Mark

Factory Certified

European Conformity

CE certified products complying with EU health, safety, and environmental protection standards.

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GMP

GMP

Good Manufacturing Practice

Our manufacturing facility adheres to strict GMP guidelines, ensuring consistent product quality.

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