Fertipro NV - FDA 510(k) Cleared Devices

Fertipro NV, is an independent manufacturer of in vitro diagnostics and cell culture media for assisted reproductive technologies and male infertility diagnosis. Founded in 1992, the company operates a state-of-the-art manufacturing facility in Beernem, Belgium, with FDA registration in Irvine, US. Fertipro holds ISO 13485 certification and participates in the MDSAP program.

The company has received 4 FDA 510(k) clearances from 4 total submissions since 2006. Obstetrics & Gynecology devices dominate the regulatory portfolio, representing 75% of submissions. The latest clearance was issued in 2025, confirming active regulatory engagement. All cleared devices are CE marked as in vitro diagnostics or medical devices, with certificates of analysis available upon request.

Fertipro's product portfolio includes culture media for embryo handling, sperm processing, and vitrification systems, alongside diagnostic kits for semen analysis and male infertility assessment. The company also offers contract manufacturing services for reproductive media and maintains product registrations across Europe, Canada, the United States, and additional markets worldwide.

Explore the complete list of FDA 510(k) cleared devices, product codes, and clearance dates in the database.

Regulatory submissions have been managed by Ducks IN A Row Compliance, LLC and Rock Quality Systems.