IMDS Operations B.V.

IMDS Operations B.V. specializes in two primary device categories: single-use vascular guide-catheters and basic coronary angioplasty balloon catheters. These devices are used in interventional cardiology to guide wires through blood vessels and dilate narrowed coronary arteries, respectively. Examples include TrapIT, ShapeIT, NHancer Rx, and Micro Rx.

IMDS Operations B.V. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including mandatory listing in the FDA’s Unique Device Identifier (UDI) database, which ensures traceability and compliance tracking for Class II devices.

IMDS Operations B.V.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides a standardized way to identify medical devices, ensuring transparency in the supply chain, facilitating post-market surveillance, and enabling healthcare providers to verify device details before use.

All devices manufactured by IMDS Operations B.V. fall under Class II classification. This classification indicates that the devices pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance, but do not require pre-market approval.