VINEHEALTH DIGITAL LIMITED

VineHealth Digital Limited specializes in software-based medical devices, specifically clinical management support software and medication reminder application software. These tools are designed to help healthcare providers and patients manage treatment plans and medication adherence more effectively. For example, VinehealthPRO supports structured clinical workflows, while Vinehealth Cancer Companion focuses on medication reminders for cancer treatment.

VineHealth Digital Limited is headquartered in the United States. The company’s location is relevant for understanding its regulatory context, as it operates under the FDA’s jurisdiction for device classification and compliance.

VineHealth Digital Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability in the healthcare supply chain.

VineHealth Digital Limited’s devices fall under the FDA’s Class I regulatory category. This classification is typically assigned to low-risk devices, such as software-based tools that do not pose significant health risks when used as intended. Class I devices often require general controls (e.g., good manufacturing practices) but may not need pre-market approval.