AmbalSoft InfoTech Private Limited

AmbalSoft InfoTech Private Limited specializes in medical imaging software solutions. Specifically, their devices include systems for capturing and managing colposcopy images (e.g., COLPOITPRO) and gynecological diagnostic imaging (e.g., CaptureITPro). These tools are designed to help clinicians store, retrieve, and analyze medical imaging data in clinical settings.

AmbalSoft InfoTech Private Limited is based in India. The company’s headquarters and operations are located within the country, though its products may be used globally.

AmbalSoft InfoTech Private Limited’s devices are listed in the EU’s eudamed database. This registry is used to track medical devices authorized for placement on the European market, ensuring transparency and compliance with EU regulations.

AmbalSoft InfoTech Private Limited’s devices fall under Class I classification. This classification is typically assigned to low-risk medical devices, such as software for image capture and management, where the risk to patient safety is minimal. Classification determines regulatory requirements, and Class I devices generally undergo less stringent scrutiny than higher-risk categories.