meso international GmbH

meso international GmbH specialises in medical imaging solutions focused on storage, display, and archiving. Their portfolio includes DICOM-compatible cameras (like the DICOM Camera Pro and Compact) for capturing diagnostic images, as well as medical-grade touchscreen monitors (e.g., IBox Touch series) designed for high-resolution 4K HDMI and SDI connectivity. These devices are engineered to integrate with hospital picture archiving systems (PACS) and support workflows in radiology, ultrasound, and other imaging environments.

meso international GmbH is headquartered in Germany, where its devices are manufactured and listed. The company adheres to EU regulatory standards for non-active medical devices, ensuring compliance with manufacturing and quality requirements applicable to its Class I devices.

meso international GmbH’s devices are registered in the EU’s eudamed database, which is the official EU-wide registry for medical devices. This registration reflects their compliance with EU requirements for Class I devices, though individual devices must still meet their specific authorisation pathways (e.g., conformity assessment procedures) before being placed on the market.

All devices manufactured by meso international GmbH fall under EU Class I, the lowest risk category for medical devices. This classification applies to devices like their DICOM cameras and touchscreen monitors, which are considered non-invasive and pose minimal risk to patients. Class I devices typically undergo a self-certification process by the manufacturer to demonstrate compliance with essential safety and performance requirements.