medigration GmbH

medigration GmbH specializes in medical imaging devices. Their portfolio includes diagnostic X-ray systems like DX|vision, software solutions for image management such as ImageBroker, digital mammography systems like MammoView, and veterinary-focused digital radiography systems like Domako. These products are designed for diagnostic imaging in both human and animal healthcare settings.

medigration GmbH is based in Germany, which places its devices under the jurisdiction of the European Union’s medical device regulations. Since the company’s products are registered in the EU’s eudamed database, this ensures compliance with EU medical device directives, including classification under relevant risk categories like Class I and Class IIb.

medigration GmbH’s devices are listed in the eudamed registry, the official EU database for medical devices. This registration is important because it demonstrates compliance with EU requirements, transparency in the supply chain, and adherence to regulatory obligations for devices classified under EU medical device directives.

medigration GmbH’s devices are classified as Class I (low-risk) and Class IIb (moderate-risk) under EU medical device regulations. Classification determines the level of regulatory oversight and requirements for compliance, such as clinical evaluations, technical documentation, and post-market surveillance. Class IIb devices require stricter scrutiny due to their higher associated risk.