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We strongly believe that quality by design and a solid quality management system coupled with compliance to all applicable standards will contribute to the success of our products.

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Our Quality Management System is ISO 13485:2016 registered and it creates a reliable framework for development and manufacture of critical assay components for the LEPZI platform.


Lepzi has got CE marking. As the manufacturer,Lepzi is now responsible for the design, manufacture and control of the registered medical device (s) and its assessment in accordance with the essential requirements of the Medical Devices Act and its implementing acts, which introduce Directive 98/79 / EC and other relevant regulations.

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