Aus Systems Pty , Ltd.

Aus Systems Pty, Ltd. specializes in two primary device categories: rectal suction biopsy systems and reusable sterilization/disinfection containers for medical instruments. Their most common product, the RB12 suction rectal biopsy system, is designed specifically for rectal biopsy procedures, while the sterilization containers ensure safe reprocessing of medical devices.

The company is headquartered in the United States. This location influences its regulatory compliance, particularly under FDA guidelines, which govern the classification and listing of its devices.

Aus Systems Pty, Ltd.’s devices are classified as Class II under FDA regulations. This classification applies to devices that generally present a moderate risk and require special controls to ensure their safety and effectiveness, such as pre-market notifications (510(k)) and post-market surveillance.

Aus Systems Pty, Ltd.’s devices are listed in the FDA’s 510(k) database, which tracks pre-market notifications for Class II devices, and the FDA’s Unique Device Identifier (UDI) database, which standardizes device identification for tracking and traceability in the healthcare system.