ULTRA CLEAN SYSTEMS, INC.

Ultra Clean Systems, Inc. specializes in two primary categories: ultrasonic-cleaning water baths and medical device cleaning agents. Their ultrasonic systems, like the Triton RACS trays and adapters, are designed for cleaning reusable medical components such as lumens and delicate instruments. Additionally, they produce cleaning solutions like Sanizyme, available in 1-gallon and 15-gallon concentrations, which are formulated to aid in the decontamination process for medical devices.

Ultra Clean Systems, Inc. is based in the United States, which means its devices must comply with U.S. regulatory standards, including those set by the FDA. Since their products fall under Class I classification—typically reserved for low-risk devices—they are subject to general controls but may still require registration, listing, and UDI assignment (like those in the FDA’s UDI database) to ensure traceability and market clearance.

Ultra Clean Systems, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which is a publicly accessible registry that tracks medical devices authorized for sale in the U.S. This database helps healthcare providers, regulators, and manufacturers verify device details, including manufacturer information, classification, and compliance status. Listing in the UDI system is mandatory for most medical devices in the U.S. to ensure transparency and traceability.

Ultra Clean Systems, Inc.’s devices are classified as Class I under FDA regulations, which is the lowest risk category for medical products. This classification applies to items like ultrasonic cleaning systems and cleaning agents, which are generally considered safe and effective when used as intended. Class I devices typically require general controls (such as proper labeling, manufacturing practices, and registration) but do not undergo rigorous pre-market review unless they pose minimal risk. The classification helps streamline compliance while ensuring basic safety standards are met.