Niramai, the deep-tech healthcare company offering an innovative AI-based, radiation-free breast cancer screening test has now received the CE mark approval, ISO 13485 and MDSAP (Medical Device Single Audit Programme) international certifications. The CE mark approval indicates that the product may be sold freely in any part of the European Economic Area (EEA) as well as applicable to many Asian, African and Middle East countries.
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source https://www.pharmatutor.org/pharma-news/2021/niramai-receives-ce-mark-approval-enabling-entry-into-eea-asia-africa-and-middle-east
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