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Cuprina Holdings Obtains ISO 13485 Certification And Dealer License For Operational IVF Media Production Facility In Singapore

Benzinga·05/05/2025 14:42:33
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Cuprina Holdings (Cayman) Limited (NASDAQ:CUPR) ("Cuprina" or "the Company"), a biomedical and biotechnology company dedicated to the development and commercialization of products for the management of chronic wounds and infertility, as well as cosmeceuticals for the health and beauty sector, today announced it had, on April 6, 2025, completed construction of, and obtained ISO 13485 certification and a dealer license for, an operational in-vitro fertilization ("IVF") media production facility in Singapore.

The ISO 13485 certification, which validates that Cuprina's quality management system at the facility meets internationally agreed standards for medical device manufacturing, was issued by United Kingdom Accreditation Service ("UKAS"), a part of the International Accreditation Forum ("IAF"). The dealer license, which confers legal authorization to businesses operating in specific activities including manufacturing, importing, or wholesaling medical devices, was issued by the Singapore Health Sciences Authority (HSA).

Cuprina will collaborate with Ferti-Craft to prepare and submit the required regulatory dossiers for registration with Singapore Health Sciences Authority ("HSA"). The goal is to obtain approval for 14 IVF media product SKUs. The project aims to secure HSA approval for commercial sale before the fourth quarter of 2026.