DEEPBLUE Medical Achieves IVDR Certification for Early Pregnancy and Ovulation Tests, Along with EU Quality Management System Certificate

Anhui DEEPBLUE Medical Technology Co., Ltd. is proud to announce a significant milestone in our commitment to global quality standards and compliance. The company has successfully obtained EU IVDR Technical Documentation Assessment Certificates for its Early Pregnancy Test and Ovulation Test, as well as the EU Quality Management System Certificate issued by TÜV SÜD Product Service GmbH.

The certifications were granted under Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR), covering both Annex IX Chapter I (Quality Management System) and Annex IX Chapter II (Technical Documentation Assessment). These approvals confirm that DEEPBLUE Medical’s products meet the rigorous requirements of the European market, ensuring the highest standards of safety, performance, and reliability.

<<< EU Quality Management System Certificate (Valid: 2025–2030)

Achieving these certificates represents a major step forward in DEEPBLUE Medical’s global strategy, strengthening our ability to expand within the European Union and other international markets. It demonstrates not only our dedication to product innovation and regulatory compliance, but also our mission to provide trusted, high-quality diagnostic solutions worldwide.

DEEPBLUE Medical will continue to uphold the principles of innovation, quality, and responsibility, contributing to the advancement of global healthcare with reliable diagnostic products.