Femasys (FEMY) announces Conformite Europeene, CE, mark certification under European Union Medical Device Regulation of the Class III FemBloc blended polymer component, marking the first regulatory approval in the world for the FemBloc System for non-surgical female permanent birth control. After European Medicines Agency, EMA, review, the Notified Body has granted CE mark certification. The regulatory approval for the blended polymer joins the earlier approval announced on March 13, 2025 for the delivery system component of FemBloc. The FemBloc System can now be marketed in the European Economic Area, which includes the 27 member states of the European Union and the 3 European Free Trade Association countries.
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