NeXgen™ 16HP Obtained IVDR Certification, Ready for Global Market

NeXgen™ 16HP has successfully obtained IVDR certification, marking a major milestone in our fully automated sample-to-result solution’s debut on the global market.

Achieving IVDR certification reaffirms that NeXgen™ 16HP meets the highest requirements for safety, performance, clinical reliability, and quality management. As one of the world’s strictest regulatory frameworks, IVDR ensures that molecular diagnostic systems deliver proven accuracy and clinical safety.

The IVDR certification not only demonstrates the quality and reliability of the NeXgen™ 16HP, but it also creates strong value for distribution partners. With this certification, partners can confidently expand their product portfolio with a fully IVDR-compliant diagnostic platform and strengthen their credibility when engaging with clinical laboratories and hospitals.

This notable achievement reflects Zinexts’ commitment to providing reliable molecular diagnostics solutions that meet the highest quality standards. It highlights our dedication in delivering innovative diagnostics that improve patient health. 

NeXgen™ 16HP offers a unique advantage for clinical and laboratory workflows by combining multiple processes into one compact platform. The system integrates high-volume nucleic acid extraction, automated PCR setup, multiplex qPCR detection, and AI-driven data reporting. As an open system, it supports any qPCR assay, providing a flexible and powerful solution for modern clinical diagnostics.