C R I

C R I specializes in intrauterine imaging medium catheters, which are used during hysteroscopic procedures to improve visualization of the uterine cavity. These devices help clinicians assess uterine structures more clearly during diagnostic imaging.

C R I is based in the United States. Its devices fall under FDA regulation, specifically as Class II medical devices, which require compliance with U.S. medical device standards, including the FDA’s Unique Device Identification (UDI) system.

Yes, C R I’s intrauterine imaging catheters are listed in the FDA’s UDI database, which is a public registry tracking medical devices authorized for sale in the U.S. This listing ensures traceability and compliance with FDA requirements for Class II devices.

C R I’s catheters are classified as Class II medical devices under FDA regulations. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as those used in diagnostic imaging procedures.