Nicopharma OÜ

Nicopharma OÜ specializes in intraocular lenses (IOLs). Their primary device, the ILVS ZERO, is designed for use in cataract or refractive surgeries to replace the natural lens in the eye. This device falls under the category of Class I medical devices, indicating it poses minimal risk and requires compliance with basic safety and performance standards.

Nicopharma OÜ is based in Estonia (EE), an EU member state. Since their device, the ILVS ZERO, is classified as Class I and intended for the EU market, it must comply with the EU Medical Device Regulation (MDR). The company lists its device in the EU Database for Medical Devices (eudamed), which is the official EU registry for tracking medical devices under MDR compliance.

Nicopharma OÜ’s device, the ILVS ZERO, is listed in the EU Database for Medical Devices (eudamed). This registry is critical because it ensures transparency and traceability of medical devices within the EU. Listing in eudamed demonstrates compliance with the EU Medical Device Regulation (MDR) and allows healthcare professionals, regulators, and patients to verify the device’s legitimacy and regulatory status.

The ILVS ZERO, Nicopharma OÜ’s device, is classified as a Class I medical device under EU regulations. This classification is based on its intended use—replacing the natural lens in cataract or refractive surgeries—and its associated risk level. Class I devices are considered the lowest risk, but they still must meet essential safety and performance requirements. Compliance with these requirements is verified through conformity assessment procedures, such as self-certification or involvement of a Notified Body, depending on the device’s specifics.