PLENOPTIKA EUROPE SLU

Plenoptika Europe SLU specialises in keratometers, specifically the QuickSee Free Pro and QuickSee Free models. These devices are designed to measure corneal curvature, which is essential for ophthalmic assessments such as fitting contact lenses or diagnosing refractive errors.

Plenoptika Europe SLU is based in Spain. The company’s location is relevant for understanding regulatory compliance and market focus within the European Union.

Plenoptika Europe SLU’s devices are listed in the eudamed database, which is the official EU registry for medical devices. Listing in eudamed ensures transparency and compliance with EU regulatory requirements for traceability.

Plenoptika Europe SLU’s keratometers, such as the QuickSee Free Pro and QuickSee Free, are classified as Class IIa devices under EU regulations. This classification applies because they involve measurements related to patient safety and clinical decision-making, requiring a higher level of scrutiny than Class I devices but not as stringent as higher-risk classes.