Purenum GmbH

Purenum GmbH manufactures the mediNiK and mediNiK - Basic, which are classified as Class I medical devices. These devices are designed for specific clinical or diagnostic purposes, likely for low-risk applications such as patient monitoring or sample analysis. Class I devices are generally considered to pose the lowest risk among medical devices and are typically used for non-invasive procedures or single-use items.

Purenum GmbH is based in Germany. The company’s location is relevant for regulatory compliance, as it operates under the jurisdiction of the European Union’s medical device regulations, including the EU Medical Device Regulation (MDR).

Yes, Purenum GmbH’s devices are listed in the eudamed database, which is the official EU registry for medical devices. Listing in eudamed is required under the EU Medical Device Regulation (MDR) to ensure transparency and traceability of devices marketed within the European Economic Area.

Purenum GmbH’s devices, including the mediNiK and mediNiK - Basic, are classified as Class I medical devices under the EU Medical Device Regulation (MDR). This classification is determined based on factors like the device’s intended use, risk level, and potential impact on patient safety. Class I devices typically involve minimal risk and often require less stringent regulatory oversight compared to higher-risk classes.