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Cupid receives CE (EU IVDR) certification for Pregnancy, Syphilis test kits

20 Oct 2025 Evaluate

Cupid 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.

Cupid’s certified IVD kits target two of the fastest-growing diagnostic categories: Pregnancy (hCG) Test Kits - Global market valued at $1.7 billion in 2024, projected to reach $2.9 billion by 2034 (CAGR around 5.4%). Syphilis Immunoassay Diagnostics - Estimated at $611 million in 2025, expected to grow to $993 million by 2034 (CAGR around 5.6%).

In addition, Cupid is in the final stages of securing CE (EU IVDR) Certification for its HIV 1 & 2 Antibody and Hepatitis B Antigen IVD kits, expected by December 2025 - products that address some of the world’s largest and most urgent diagnostic markets.

Cupid manufactures and markets varieties of male and female condoms, water-based lubricant, latex dental dams and probe covers. The company has a diverse product basket available in many countries worldwide.


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