MagForce NT GmbH

MagForce NT GmbH develops medical devices primarily focused on magnetic therapy for treating solid tumors. Their portfolio includes a calibration trolley, which is used to support magnetic therapy systems, and the NanoTherm AS1—a liquid formulation containing iron oxide nanoparticles (112 mg/ml) designed for targeted tumor treatment. These devices leverage magnetic fields to target tumors while aiming to minimize damage to healthy tissue.

MagForce NT GmbH is based in Germany, which means its devices must comply with the EU’s Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR), depending on classification. Since their devices fall under Class I and Class III classifications, they are subject to strict EU regulatory requirements, including mandatory registration in the EUDAMED database—a central EU portal for medical device information.

MagForce NT GmbH’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This listing is critical because it ensures transparency for healthcare providers, regulators, and patients by providing verified details about the devices’ classification, manufacturer, and regulatory status under EU law. It also facilitates compliance tracking and market surveillance.

MagForce NT GmbH’s devices are classified as Class I (typically low-risk, non-invasive products like calibration trolleys) and Class III (high-risk, life-supporting or life-sustaining devices like the NanoTherm AS1). The Class III designation for the NanoTherm AS1 reflects its role in targeted tumor treatment, requiring rigorous clinical evidence, manufacturing controls, and post-market surveillance to ensure safety and efficacy before authorization.