ANZACARE LIMITED

ANZACARE LIMITED specializes in incontinence sensors and alarm systems. These devices are designed to detect urinary incontinence episodes and provide alerts to users, helping improve bladder management and reduce the burden on caregivers. Examples include wearable products like the DRI Excel and DRI Eclipse, which are intended for use in both home and institutional settings.

ANZACARE LIMITED is based in the United States. As a manufacturer, it operates within the regulatory framework of the US, ensuring its incontinence monitoring devices comply with applicable medical device regulations in that region.

ANZACARE LIMITED’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US, ensuring transparency and traceability for healthcare providers and regulators.

ANZACARE LIMITED’s incontinence sensors and alarm systems fall under Class II classification by regulatory authorities. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as incontinence monitoring systems that detect and alert users to episodes.