Xuzhou Kaixin Electronic Instrument Co., Ltd.

Xuzhou Kaixin Electronic Instrument Co., Ltd. specializes in bladder volume ultrasound imaging systems. These devices are primarily designed for non-invasive measurement of residual urine volume in the bladder, helping assess urinary retention or post-voiding bladder emptying.

The company is based in the United States. This location is relevant for regulatory compliance and distribution, particularly for devices marketed or used within the U.S. healthcare system.

The company’s devices, such as the Bladder Scanner, are classified as Class II under FDA regulations. This classification indicates moderate risk and requires compliance with specific controls, including performance standards and post-market surveillance, to ensure safety and effectiveness.

Yes, the company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This database helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for healthcare providers and regulators.