Genesis Industries, Incorporated

Genesis Industries, Incorporated specializes in reprocessed medical devices used in assisted reproduction procedures. Specifically, they produce assisted reproduction needles and trial transfer catheters, which are designed for single-use applications in fertility treatments, such as needle insertion and embryo transfer.

Genesis Industries, Incorporated is based in the United States. The company’s operations and regulatory compliance align with U.S. federal requirements for the devices it manufactures.

Genesis Industries’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry tracks Class I medical devices, ensuring transparency and traceability for authorized products under U.S. federal regulations.

Genesis Industries’ devices fall under the FDA’s Class I classification. Class I devices are generally considered to pose the lowest risk and are subject to general controls, including compliance tracking through systems like the UDI database.