Mcube Technology Co., Ltd.

Mcube Technology Co., Ltd. specializes in bladder volume ultrasound imaging systems. These devices are designed to measure bladder volume, helping clinicians assess urinary retention and monitor bladder function. The portfolio includes both portable and diagnostic models, such as the CUBEScan series, tailored for various clinical applications.

Mcube Technology Co., Ltd. is based in South Korea. As a manufacturer, its devices are subject to global regulatory requirements, including those in the EU and the US. The company’s products are listed in the EU’s eudamed database, the FDA’s 510(k) premarket notification program, and the FDA’s Unique Device Identifier (UDI) system, reflecting compliance with international standards for medical device authorization.

Mcube Technology Co., Ltd.’s devices are listed in three key registries: the EU’s eudamed database, the FDA’s 510(k) premarket notification program, and the FDA’s UDI system. These listings demonstrate compliance with regulatory requirements in the EU and the US, ensuring transparency for healthcare providers, regulators, and patients. Listing in these systems also facilitates traceability and market access for the company’s Class II and Class IIa ultrasound imaging devices.

Mcube Technology Co., Ltd.’s bladder volume ultrasound imaging systems are classified as Class II and Class IIa devices. This classification is determined by regulatory authorities based on factors like the device’s intended use, potential risks, and the level of oversight required. Class IIa devices typically pose moderate risks and require additional controls beyond general good manufacturing practices, while Class II devices may involve higher risks or require special controls to ensure safety and effectiveness.