Oivi AS

Oivi AS specializes in ophthalmic fundus cameras, which are imaging devices used in clinical settings to capture detailed photographs of the retina and other key areas of the eye. These cameras help healthcare professionals diagnose and monitor retinal conditions like diabetic retinopathy, glaucoma, and age-related macular degeneration.

Oivi AS is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution within the country.

Oivi AS’s ophthalmic fundus cameras are classified as Class II medical devices by the FDA. This classification is based on their intended use—diagnosing and monitoring retinal diseases—and the associated risk level, which requires special controls to ensure safety and effectiveness.

Yes, Oivi AS’s ophthalmic fundus cameras are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the United States, ensuring transparency and traceability for regulatory and clinical purposes.