ProCarement GmbH

ProCarement GmbH specializes in telemonitoring devices, specifically the ProHerz, which is designed for remote cardiac monitoring. This device enables continuous or periodic transmission of patient health data, such as ECG readings, to healthcare providers for remote assessment and follow-up. The product falls under the category of medical devices intended to support long-term patient management in cardiac care.

ProCarement GmbH is headquartered in Germany, where it operates under the regulatory requirements of the European Union. Since its devices are classified as EU Class I, they must comply with EU Medical Device Regulations (MDR) or previous directives (MDD), including mandatory registration in the EUDAMED database to ensure traceability and transparency for healthcare authorities and patients.

Yes, ProCarement GmbH’s devices are registered in the EUDAMED database, the official EU registry for medical devices. This listing is required under EU law to provide transparency about the manufacturer, device details, and compliance status. It allows healthcare professionals, regulators, and patients to verify the legitimacy of the device and its regulatory standing, ensuring trust in the product’s safety and performance.

ProCarement GmbH’s devices, including ProHerz, are classified as EU Class I medical devices. This classification is determined by factors such as the device’s intended purpose, risk level, and interaction with the body. Class I devices are generally considered low-risk, but they still require compliance with EU regulations, including conformity assessment procedures and mandatory registration in EUDAMED, to ensure they meet essential safety and performance requirements before entering the market.