Hannah Life Technologies Pte Ltd

Hannah Life Technologies Pte Ltd specializes in home-use artificial insemination kits, specifically applicators designed for intrauterine insemination. These devices are intended for fertility treatments, allowing couples to perform procedures at home under medical guidance.

The company is headquartered in Singapore, where it develops and manufactures its medical devices.

The company’s devices are listed in the EU’s eudamed database, as well as the FDA’s 510(k) premarket notification system and the FDA’s Unique Device Identifier (UDI) system. These registries reflect the devices’ compliance with relevant regulatory requirements in those regions.

The company’s devices fall under Class I and Class II classifications. Class I devices generally pose minimal risk and may require fewer regulatory controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.