Medisana GmbH

Medisana GmbH produces two primary types of devices: handheld electric massagers for muscle relaxation and pain relief, and infrared patient thermometers designed to measure ear and skin temperature. These devices are intended for both consumer and clinical use, providing non-invasive therapeutic and diagnostic solutions.

Medisana GmbH is based in Germany, which means its devices must comply with the European Union’s Medical Device Regulation (MDR). The company’s products are classified under MDR as either Class I or Class II devices, depending on their risk level and intended use.

Yes, Medisana GmbH’s devices are included in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. These listings help ensure transparency and traceability of medical devices within their respective regulatory frameworks.

Under the EU Medical Device Regulation (MDR), Medisana GmbH’s devices are classified as either Class I or Class II. The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety. For example, infrared thermometers may fall under Class II due to their diagnostic role, while massagers are typically Class I.

A handheld electric massager is generally classified as Class I under EU MDR because it poses minimal risk to users. These devices are non-invasive, low-risk, and intended for general wellness rather than life-supporting or life-sustaining functions. Classification is determined by risk assessment criteria outlined in the regulation.