Okuvision GmbH

Okuvision GmbH specializes in non-invasive visual stimulation devices. Their portfolio includes portable pulse stimulators like the OkuStim Pulse Lite and OkuStim 2, which are designed for retinal therapy. They also produce electrode packages (such as OkuEl Electrode and OkuEl M) and accessories like counter electrodes. Additionally, they offer the OkuSpex, a diagnostic device used for retinal assessment.

Okuvision GmbH is headquartered in Germany. The company’s location is relevant for understanding its regulatory framework and compliance with EU medical device regulations.

Okuvision GmbH’s devices are listed in the EU’s eudamed database, which is the official registry for medical devices under EU medical device regulations. This ensures transparency and traceability of their products within the European market.

Okuvision GmbH’s devices are classified under the EU Medical Device Regulations as either Class I or Class IIa. The classification depends on factors like the intended use, risk level, and potential impact on patient safety. Class I devices are generally low-risk, while Class IIa devices pose a slightly higher risk and require additional regulatory scrutiny.