BioGenetics CO., LTD.

BioGenetics CO., LTD. specializes in basic male condoms made from Hevea latex. Their product line includes single-unit packaging, multi-packs like the 3-piece sets (e.g., UNIDUS LONG LOVE), bulk gross cases, and shipping cartons designed for distribution. These are intended for contraceptive use and are classified as Class II devices.

BioGenetics CO., LTD. is headquartered in the United States. The company’s location is relevant for regulatory compliance and distribution, particularly since its devices are listed in the FDA’s Unique Device Identifier (UDI) database.

BioGenetics CO., LTD.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory compliance and market surveillance.

BioGenetics CO., LTD.’s male condoms are classified as Class II medical devices. This classification is determined by the FDA based on factors like the device’s intended use, potential risks, and benefits. Class II devices typically require special controls in addition to general controls to ensure safety and effectiveness.