NEMOTO KYORINDO CO., LTD.

NEMOTO KYORINDO CO., LTD. specializes in mobile, line-powered systems that inject contrast media during medical imaging. Their devices are designed specifically for angiography and MRI procedures, ensuring accurate and controlled delivery of contrast agents to improve diagnostic clarity. These systems are tailored to enhance imaging quality in clinical settings.

The company is based in the United States. This location allows them to operate within the regulatory framework of the FDA, which governs the classification and listing of their medical devices.

NEMOTO KYORINDO CO., LTD.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, helping healthcare providers and regulators identify and verify the devices in use.

NEMOTO KYORINDO CO., LTD.’s devices fall under Class II classification in the FDA’s regulatory system. Class II devices are those posing moderate risk and require special controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.