KOBA Vision

KOBA Vision specializes in video magnifiers and portable reading machines tailored for individuals with low vision or blindness. These devices include handheld and mounted solutions like the Vocatex Plus, Quartz, EasyViewer, ZoomCam Speech, and Iris series. They provide visual magnification and text-to-speech functionality to assist with reading and document inspection.

KOBA Vision is headquartered in Belgium. Since its devices fall under Class I medical device classification, they are subject to EU regulatory requirements. This includes compliance with applicable EU medical device directives and registration in the EUDAMED database, ensuring adherence to safety and performance standards for Class I devices.

Yes, KOBA Vision’s devices are listed in the EUDAMED registry. EUDAMED is the European Union’s database for medical devices, where manufacturers register their products to demonstrate compliance with EU regulations. Listing in EUDAMED is mandatory for Class I devices to ensure transparency and traceability within the EU market.

KOBA Vision’s devices are classified as Class I medical devices under EU regulations. This classification applies to products posing minimal risk, such as video magnifiers and reading machines. Class I devices typically require compliance with basic safety and performance requirements but may not need additional conformity assessments beyond manufacturer self-certification.