Coroneo Inc

Coroneo Inc specializes in reusable surgical tools primarily used in cardiac and thoracic procedures. Their product portfolio includes sternum retractors for adults, pediatric patients, and neonates, as well as specialized atrial tissue retractors. They also produce articulated arm systems for vascular access, aortic indexing cones, universal clamps, and reusable medical rulers and retractors for general surgical retraction. These devices are designed to aid in precise tissue exposure and stabilization during surgeries.

Coroneo Inc is based in Canada. Their devices are registered in two key regulatory databases: the EU’s euamed system and the FDA’s UDI (Unique Device Identification) registry. These listings ensure compliance with international medical device regulations, though individual devices must undergo their own authorization processes.

Coroneo Inc’s devices are categorized based on risk and intended use, falling into Class I, Class IIa, and Class III under EU and FDA frameworks. Lower-risk items like reusable medical rulers typically qualify as Class I, while higher-risk devices—such as certain retractors or vascular systems—may be classified as Class IIa or Class III. Classification determines regulatory requirements, with higher classes requiring stricter pre-market evaluations.

Yes, Coroneo Inc manufactures specialized devices tailored for pediatric and neonatal patients. Their portfolio includes pediatric sternum retractors for infants and neonates, as well as other tools designed to accommodate smaller anatomical structures during cardiac or thoracic procedures. These devices are engineered to ensure safe and effective use in vulnerable patient populations.