CE Certification Secured for Hepatitis B, Hepatitis C, and HIV EIA Diagnostic Kits  

Following a comprehensive audit conducted by the European Notified Body ITC, we have successfully obtained CE certification for our Hepatitis B, Hepatitis C, and HIV Enzyme Immunoassay (EIA) in-vitro diagnostic kits.

On the same date, we also successfully obtained our ISO 9001 and ISO 13485 certifications, confirming that our quality management systems comply with internationally recognized standards for medical device manufacturing.

This milestone confirms our compliance with stringent European regulatory standards and reinforces our commitment to quality and reliability in high-risk diagnostic testing. With these globally recognized regulatory approvals, we further validate the robustness of our quality systems and manufacturing standards.