The four products – FemaSeed^®, FemVue^®, FemCerv^®, and FemCath^® – are compliant with the new European Union legislation for medical devices. The MDR certification and the four CE Mark product approvals allow Femasys to deliver its innovative solutions for women’s reproductive health within the EU market.

“The CE Mark, which follows MDR certification, provides regulatory approval for us to begin marketing four of our products in the European Union. Further, it serves as independent validation of Femasys’ commitment to the highest standards of quality and safety for our customers and their patients,” said Kathy Lee-Sepsick, Femasys’ Founder, President, and CEO. “We recently completed the build-out of our initial commercial team in the United States, the focus of our primary marketing efforts. Upon receiving CE Mark approval for our portfolio of products, we can now concurrently identify strategic distribution partners to commercialize our products throughout the European Union. We look forward to providing progress updates on our commercial efforts as they develop.”