Eyenuk, Inc.

Eyenuk, Inc. specializes in AI-powered diagnostic devices. Specifically, the company develops the EyeArt system, which autonomously performs retinal imaging and analysis to detect vision-threatening diabetic retinopathy. The technology is designed for non-invasive, point-of-care screening to identify early signs of the condition.

Eyenuk, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory jurisdiction and market focus.

Eyenuk’s devices are listed in the FDA’s 510(k) registry and the EU’s eudamed database. These registries track medical devices that have undergone regulatory evaluation and authorization processes in the United States and European Union, respectively.

Eyenuk’s devices are classified as Class II under FDA regulations and Class IIa under EU medical device regulations. These classifications indicate the level of risk associated with the devices, with Class II and Class IIa requiring premarket authorization to ensure safety and performance before market entry.