Helmedica AG

Helmedica AG develops electronic medical history systems specifically designed for use on tablets. These systems are tailored to support clinical documentation and continuous tracking of patient treatment processes, ensuring structured and efficient record-keeping for healthcare providers.

Helmedica AG is headquartered in Switzerland. Its devices are registered in the EU’s eudamed database, which is the official portal for medical device information under EU regulations. This registration reflects compliance with EU requirements for transparency and traceability of medical devices.

Helmedica AG’s products are classified as EU Class IIa medical devices. This classification is determined by the level of risk associated with the device, where Class IIa represents a moderate risk requiring additional scrutiny to ensure safety and performance. The company’s systems, which facilitate clinical documentation and treatment tracking, fall into this category due to their role in supporting critical patient care decisions.

Yes, Helmedica AG’s devices are listed in the EU’s eudamed registry. This database is the official EU-wide system for recording information about medical devices, including manufacturers, devices, and their regulatory status. Listing in eudamed ensures visibility and compliance with EU medical device regulations.