JUST-ON

Just-On specializes in disposable medical devices for gynecological procedures. Specifically, the company produces a histeroscopy device designed for both diagnostic and operational use, enabling clear visualization of the uterine cavity during outpatient examinations. This device is intended to enhance clinical accuracy and safety in minimally invasive gynecological interventions.

Just-On is based in Italy. Its histeroscopy device is intended for use within the European Union, where it must comply with applicable medical device regulations, including classification and registration requirements.

Just-On’s histeroscopy device falls under Class I classification in the EU. This classification is determined by factors such as the device’s intended use, risk level, and whether it is invasive or non-invasive. Class I devices are generally considered low-risk but still require compliance with EU Medical Device Regulations (MDR) or previous directives, including registration in databases like EUDAMED.

Yes, Just-On’s histeroscopy device is listed in the EUDAMED database. EUDAMED is the European Union’s centralised registry for medical devices, where manufacturers must register their products to demonstrate compliance with EU regulations. Listing in EUDAMED is a requirement for devices placed on the market within the EU.