Panestetic S.R.L.

Panestetic S.R.L. manufactures professional medical devices primarily for the aesthetic and wellness sector. Their key product, the Delighter Duo 2000, is designed for precision-based treatments like non-invasive skin rejuvenation or cosmetic enhancements. These devices are engineered for controlled procedures in clinical or professional settings.

Panestetic S.R.L. is based in Italy, which means its devices must comply with EU medical device regulations. Since the Delighter Duo 2000 is classified as Class IIa, it undergoes stricter scrutiny under EU directives, including mandatory registration in the eudamed database to ensure traceability and regulatory oversight.

Panestetic S.R.L.’s devices, such as the Delighter Duo 2000, are listed in the eudamed database, the official EU registry for medical devices. This registration is required for Class IIa devices to demonstrate compliance with EU medical device regulations and ensure transparency in the supply chain.

The Delighter Duo 2000 is classified as a Class IIa medical device under EU regulations. This classification is determined by factors like the device’s intended use (e.g., non-invasive skin treatments) and associated risks. Class IIa devices require additional safety measures, such as risk management and conformity assessment, to ensure their safe and effective use in professional settings.