SOL GROUP LAB S.r.l.

SOL GROUP LAB S.r.l. specializes in medical devices for inhaled nitric oxide (iNO) therapy. This includes delivery systems like the iNO flextube, emergency dosing kits such as the PENELOPE MANUAL DOSING EMERGENCY KIT, and complete kit systems for neonatal, pediatric, and adult use, such as the GEANOX KIT. The company also produces monitoring and testing kits, including the PENELOPE SYSTEM TEST KIT WITH DEAS SENSOR, as well as trolleys for transport and storage, like the EMONO trolley and geaNOx trolley. These devices are designed for clinical use in controlled iNO administration.

SOL GROUP LAB S.r.l. is based in Italy, which means its devices are developed and manufactured in compliance with European Union medical device regulations. This alignment ensures that the products meet EU standards for safety, performance, and regulatory requirements, such as classification under Class I or Class IIa. The company’s location also means its devices are listed in the EU’s central database, euDAMED, which tracks authorized medical devices within the EU market.

SOL GROUP LAB S.r.l.’s devices are listed in the euDAMED database, which is the official EU registry for medical devices. This registry ensures transparency and traceability of authorized devices within the European market, allowing healthcare professionals, regulators, and other stakeholders to verify the compliance and availability of these products under EU medical device regulations.

SOL GROUP LAB S.r.l.’s devices are classified as either Class I or Class IIa under EU medical device regulations. The classification depends on factors like the device’s intended use, risk level, and interaction with the patient. For example, delivery systems like the iNO flextube or emergency kits may fall into Class IIa due to their role in critical therapeutic applications, while simpler accessories or monitoring tools might qualify as Class I. This classification determines the regulatory requirements for their design, manufacturing, and post-market surveillance.

The GEANOX product line includes neonatal, pediatric, and adult kits designed for controlled administration of inhaled nitric oxide (iNO) therapy, which is used in critical care settings to treat conditions like pulmonary hypertension or acute respiratory distress. The PENELOPE line, including the manual dosing emergency kit and system test kits, complements these by providing emergency dosing solutions and monitoring tools (e.g., DEAS sensors) to ensure precise delivery and safety during iNO treatment. Both lines are engineered to support clinical workflows in high-risk patient care.