$Femasys (FEMY.US)$ 8k report: On June 20, 2024, Femasys Inc...

$Femasys(FEMY.US)$ 8k report: On June 20, 2024, Femasys Inc., a biomedical company specializing in women's health, announced the receipt of CE Mark approval for four of its products, enabling the start of commercialization efforts in Europe. The approved products, which include FemaSeed, FemVue, FemCerv, and FemCath, comply with the European Union Medical Device Regulation (EU MDR). This regulatory milestone follows the company's recent completion of its commercial team in the United States and allows Femasys to seek strategic distribution partners within the EU. The CE Mark approval comes shortly after the company obtained the MDR certification, with the assistance of TÜV SÜD, a company that provides testing, certification, and risk management services. Femasys' portfolio also features FDA-cleared products and a lead product candidate, FemaSeed Intratubal Insemination, which is already approved in Canada and Europe, as well as FemBloc, a non-surgical permanent birth control method in late-stage clinical development.