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Rotarex Meditec received medical device regulation (MDR) certificate
In January 2025, Rotarex reaffirmed the highest quality of its medical devices range by receiving the European Union’s Medical Device Regulation (MDR) final Certificate, directive 2017/745. Performant and reliable, Rotarex pressure regulators and valves with integrated pressure regulator continue to serve patients' well-being while adhering to all necessary safety requirements.
The MDR certification demonstrates a notable advancement in medical technologies, harmonizing the regulatory review and validation process across all member countries of the European Union. This new regulation replaces the earlier Medical Devices Directive (MDD) to reflect changes in the medical sector over the last 20 years and to guarantee a high level of reliability, and safety while supporting technological innovation.
The final certification marked the outcome of a meticulous and long-term process, securing its rightful place among Rotarex’s extensive list of certifications.
Known as a worldwide leader not only in the medical field but also in other gas-related industries, Rotarex serves sectors such as semiconductors, pharmaceuticals, industrial, fire suppression, LPG, beverages, and automotive.
The full list of certifications is available here: https://rotarex.com/certifications
Contact: Mathieu Chatelet, Senior Sales Manager MediTec
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