Gimbo Medical Technology Shenzhen Co., Ltd.

Gimbo Medical Technology Shenzhen Co., Ltd. specializes in producing media and cryostorage solutions primarily used in assisted reproductive technology (ART). Their portfolio includes IVF culture media for different developmental stages (such as cleavage and blastocyst), warming and vitrification media for embryo preservation, gamete buffers for sperm and egg handling, and cryostorage straws for tissue cryopreservation. They also offer flushing and retrieval media for oocytes and single-step culture media designed to support embryo development throughout the IVF process.

The company is based in the United States. While its name includes 'Shenzhen,' the operational headquarters and regulatory presence are established in the US, where its devices are developed and marketed.

Gimbo Medical Technology’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track devices that have undergone the required regulatory pathways for Class II medical devices in the US.

All of Gimbo Medical Technology’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls (such as performance standards or post-market surveillance) to ensure safety and effectiveness. Class II devices typically require premarket notification (510(k)) clearance before commercial distribution.