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Cupid Limited Receives CE (EU IVDR) Certification for HIV and Hepatitis B Test Kits
Cupid Limited has secured CE (EU IVDR) certification for its HIV 1&2 and Hepatitis B surface antigen test kits, meeting stringent European regulatory standards. This approval allows the company to market these diagnostic kits across the European Economic Area and other global markets that recognize CE marking. The move is part of Cupid's strategy to diversify its portfolio beyond condoms into the high-growth in-vitro diagnostics (IVD) sector. This certification significantly enhances the company's ability to participate in large-scale international government tenders and public health programs.
Key Highlights
Received CE (EU IVDR) certification for HIV 1&2 and Hepatitis B IVD test kits under Regulation (EU) 2017/746.
Enables market access to the European Economic Area (EEA) and other CE-recognized international markets.
Enhances eligibility for government tenders and multilateral agency programs like WHO and UNFPA.
Supports the company's strategic transition into a broader innovation-led healthcare and diagnostics platform.
Company is also expanding manufacturing capacity by 1.5x, adding 770 million male condoms annually.
💼 Action for Investors
Investors should monitor the revenue contribution from the IVD segment as these certifications open high-margin regulated markets. The successful diversification beyond the core condom business could lead to a valuation re-rating if execution remains strong.