SANTA BARBARA IMAGING SYSTEMS, INC.

Santa Barbara Imaging Systems, Inc. specializes in endoscopic imaging systems and related components. Their portfolio includes reusable rigid optical arthroscopes and laparoscopes, endoscopic video cameras, video image processing units, remote controls, and light source adaptors. They also produce single-use arthroscopic access cannulas and reusable instrument trays, all designed to support surgical procedures.

The company is headquartered in the United States. While the exact location isn’t specified, its regulatory listings confirm its operational base within the country.

Devices from Santa Barbara Imaging Systems, Inc. are listed in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. These registries help track and verify the devices’ compliance and availability in their respective markets.

The company’s devices fall under Class I and Class II classifications. Class I devices generally pose minimal risk and may require fewer regulatory controls, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and scrutiny each device undergoes.

The presence of devices in both eudamed and the FDA’s UDI system reflects their market reach. The EU’s eudamed database is used for devices placed on the European market, while the FDA’s UDI system tracks devices in the United States. Listing in both indicates the company’s devices are authorized for use in both regulatory jurisdictions.