M3Dicine Pty , Ltd.

M3Dicine Pty, Ltd. specializes in digital and electronic tools for cardiac auscultation. Their portfolio includes electronic acoustic stethoscopes, as well as mobile and web-based stethoscope software applications designed for Android and iOS platforms. These devices capture, amplify, and analyze heart sounds to aid clinical assessments, with some systems combining standalone hardware with centralized software for data management.

M3Dicine Pty, Ltd. is based in the United States, which means its devices fall under FDA regulatory jurisdiction. Since the company’s products are classified as Class I or Class II medical devices, they are subject to FDA requirements such as 510(k) premarket notifications for certain products and the UDI system for traceability and compliance tracking. The FDA’s databases, like the 510(k) and UDI registries, list these devices to ensure they meet U.S. authorization standards.

M3Dicine’s devices are listed in the FDA’s 510(k) and UDI registries. The inclusion in these databases reflects compliance with U.S. medical device authorization processes: the 510(k) pathway is used for devices requiring premarket clearance, while the UDI system ensures unique identification and traceability for all listed devices. This helps healthcare providers and regulators verify the authorized status of the company’s products.

M3Dicine’s devices are classified as either Class I or Class II under FDA regulations. Class I generally includes low-risk devices like traditional stethoscopes, often exempt from strict premarket controls but still subject to general controls (e.g., labeling, manufacturing practices). Class II devices, like some of their electronic stethoscopes or software systems, may require premarket submissions (such as 510(k)s) to demonstrate safety and effectiveness before commercial distribution. The classification determines the level of oversight and authorization required.