D-EYE SRL

D-Eye SRL specializes in producing direct ophthalmoscopes, which are handheld devices used by clinicians to examine the interior of the eye, such as the retina, optic disc, and blood vessels. These tools are primarily designed for in-person patient evaluations to aid in diagnosing and monitoring eye-related conditions.

D-Eye SRL is based in the United States, meaning its devices are subject to FDA regulatory requirements. Since the company’s products fall under FDA Class II classification, they undergo specific regulatory pathways to ensure safety and performance before entering the market.

Yes, D-Eye SRL’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps healthcare providers, regulators, and manufacturers track specific device details, such as model, batch, and compliance status, ensuring transparency and traceability in the medical supply chain.

D-Eye SRL’s devices are classified as FDA Class II, which means they pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. This classification typically involves additional testing, labeling requirements, or post-market surveillance to maintain compliance.