Cupid Limited Achieves CE Certification for In-Vitro Diagnostic Devices

Mumbai (Maharashtra) [India], October 18: Cupid Limited—renowned as a leading Indian healthcare and diagnostics manufacturer—has made a significant stride in its global ambitions. The company has announced that it has received CE (EU IVDR) Certification for two of its primary in-vitro diagnostic (IVD) devices: the CupiSURE Pregnancy (hCG) Test Kit and the CupiKIT Syphilis Antibody Test Kit.

This certification validates Cupid Limited’s compliance with the European Union Regulation (EU) 2017/746 (IVDR), permitting the distribution of these diagnostic kits throughout the European Economic Area and other CE-recognized international markets. This milestone marks a pivotal shift for Cupid, transitioning from being primarily an Indian healthcare exporter to a recognized global IVD solutions provider.

A Promising Global Market Outlook

The market landscape for diagnostic kits is notably bright, especially for the arenas that Cupid is venturing into. The CupiSURE Pregnancy (hCG) Test Kits, for example, are part of a global market valued at approximately USD 1.7 billion in 2024, expected to escalate to USD 2.9 billion by 2034, reflecting a compound annual growth rate (CAGR) of around 5.4%.

Similarly, the market for Syphilis Immunoassay Diagnostics is poised for growth. Estimated at USD 611 million in 2025, it is predicted to reach USD 993 million by 2034, showing a healthy CAGR of about 5.6%. These figures underscore the increasing demand for effective and reliable diagnostic tools worldwide.

In a further strategic move, Cupid is in the final phases of securing CE (EU IVDR) Certification for its HIV 1 & 2 Antibody and Hepatitis B Antigen IVD kits, with expectations for completion by December 2025. These products are essential, addressing significant needs in global health diagnostics. The HIV 1 & 2 antibody diagnostic market is estimated to be worth USD 3.6 billion in 2025, set to expand to USD 6.1 billion by 2030 (CAGR ~10.7%). On the other hand, Hepatitis B Antigen diagnostics are valued at USD 1.3 billion in 2024, likely to exceed USD 2.0 billion by 2033 (CAGR ~4.2%).

Strategic Significance for Cupid Limited

The CE (EU IVDR) approvals unlock numerous opportunities for Cupid Limited. The company can now actively participate in tenders across Europe, Africa, and Latin America, focusing on crucial areas such as maternal health, sexually transmitted disease (STD) management, and overall infectious-disease screening.

By leveraging its cost-effective, high-quality manufacturing processes based in India, Cupid is well-positioned to provide competitively priced IVD solutions on a global scale. These certifications also highlight Cupid’s commitment to diversifying beyond its historical focus on sexual-health products and moving into broader preventive and diagnostic healthcare realms, particularly as the global healthcare landscape shifts toward early detection and rapid testing capabilities.

Mr. Aditya Kumar Halwasiya, the Chairman and Managing Director of Cupid Limited, expressed enthusiasm about this milestone achievement. He noted that the CE (EU IVDR) Certification for the Pregnancy and Syphilis Antibody IVD kits affirms Cupid’s adherence to global quality standards and technical excellence. This certification not only opens substantial market opportunities but also aligns with the company’s vision to become an integrated diagnostic player with a globally certified product suite.

Looking ahead, Cupid aims to establish a robust international presence, ensuring that accurate and affordable diagnostics are accessible to diverse populations. The journey of Cupid Limited symbolizes not just a local company making strides on the global stage, but also the narrative of innovation and commitment to improving public health worldwide.

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