Grossoptic d.o.o.

Grossoptic d.o.o. specializes in ophthalmic imaging devices. Specifically, they produce the Grossoptic MAX, which is designed for imaging parts of the eye, such as the retina or anterior segment, commonly used in clinical examinations.

Grossoptic d.o.o. is based in Serbia. Since their device, the Grossoptic MAX, is classified as Class I and listed in the EU’s eudamed registry, it indicates compliance with EU medical device regulations, though the company itself is not approved—only the device is authorised under applicable EU directives.

Grossoptic d.o.o.’s devices, such as the Grossoptic MAX, are listed in the EU’s eudamed registry. This matters because eudamed is the official EU database for medical devices, ensuring transparency and traceability for regulators, healthcare providers, and patients regarding authorised devices in the market.

The Grossoptic MAX is classified as a Class I medical device. This classification implies it poses minimal risk to patients and users, requiring fewer regulatory controls compared to higher-risk devices. Class I devices typically undergo basic conformity assessment procedures, such as self-certification by the manufacturer, to ensure compliance with essential safety and performance requirements.