Fertiligent, Ltd.

Fertiligent, Ltd. specializes in devices used for assisted reproduction, specifically intrauterine insemination (IUI) products. Their portfolio includes slow-release IUI catheter kits and transfer catheter sets, which are designed to aid in the precise placement of sperm during fertility treatments in clinical settings.

Fertiligent, Ltd. is headquartered in the United States. The company’s location is relevant for understanding regulatory oversight, as its devices are subject to FDA requirements.

Fertiligent, Ltd.’s devices fall under Class II classification by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as design validation and post-market surveillance.

Yes, Fertiligent, Ltd.’s devices are included in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system. These registries track devices that have undergone regulatory review (e.g., 510(k) clearance) and are assigned a UDI for traceability in the healthcare system.

The FERTILIGENT SLOW RELEASE IUI CATHETER KIT is designed to facilitate controlled sperm deposition during intrauterine insemination procedures. The slow-release mechanism helps maintain sperm viability and positioning within the uterus, potentially improving fertilization outcomes in assisted reproduction treatments.