Cupid achieves CE (EU IVDR) certification for pregnancy and syphilis test kits
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Cupid achieves CE (EU IVDR) certification for pregnancy and syphilis test kits

  • By IPP Bureau | October 19, 2025

Cupid Limited, a leading Indian healthcare and diagnostics manufacturer, has been granted CE (EU IVDR) certification for two of its key in-vitro diagnostic (IVD) devices - the CupiSURE Pregnancy (hCG) Test Kit and the CupiKIT Syphilis Antibody Test Kit.

These certifications confirm compliance with the European Union Regulation (EU) 2017/746 (IVDR), authorizing Cupid to distribute these kits across the European Economic Area and other CE-recognized global markets. The development marks a major step in Cupid's transition from an Indian healthcare exporter to a globally certified IVD solutions provider.

With these CE (EU IVDR) approvals, Cupid can now participate in European, African, and Latin American tenders for maternal health, STD, and infectious-disease screening.

Leverage its low-cost, high-quality manufacturing base in India to deliver competitively priced global IVD solutions.

The certifications also reinforce Cupid's commitment to diversifying beyond sexual-health products into the broader preventive and diagnostic healthcare space, aligning with the global shift toward early detection and rapid testing.

Commenting on the development, Aditya Kumar Halwasiya, Chairman and Managing Director said, "The CE (EU IVDR) Certification for our Pregnancy and Syphilis Antibody IVD kits is a milestone achievement that validates Cupid's global quality standards and technical excellence. These certifications open up huge opportunities for us across Europe, Africa, and Asia. With HIV 1&2 Antibody and Hepatitis B Antigen kits on track for approval by December 2025, Cupid is poised to become one of India's few integrated diagnostic companies with a globally certified product suite. We aim to build a strong international footprint and make accurate, affordable diagnostics accessible to all."

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