XUZHOU KAIXIN ELECTRONIC INSTRUMENT CO., LTD.

Xuzhou Kaixin Electronic Instrument Co., Ltd. specializes in ophthalmological and bladder-related diagnostic devices. Their product line includes ultrasonic measuring instruments and A/B mode ultrasound scanners for eye examinations, as well as bladder volume testers and fully digital ultrasonic diagnostic instruments designed for non-invasive bladder volume assessment. These devices are developed to assist in precise medical diagnostics.

The company is headquartered in China, specifically in Xuzhou. This location serves as the primary base for its operations, research, and manufacturing of its medical devices.

The company’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry, and the FDA’s 510(k) registry in the United States. These registries track devices that have undergone the necessary regulatory processes for market authorization in those regions.

The company’s devices fall under Class II and Class IIa classifications. These classifications are determined based on the level of risk associated with the device, with Class IIa representing moderate risk and Class II covering higher-risk devices that require additional regulatory oversight to ensure safety and performance.