Mindray defibrillators amongst the world’s first to receive EU Medical Device Regulation certification

Medical device provider Mindray has become one of the first manufacturers in the world to receive certification for its defibrillators, under the European Union’s newest Medical Device Regulation (MDR).

One of Europe’s largest providers of defibrillators, Mindray supplies the devices to healthcare providers and community settings across many parts of the continent, where they are used in life-threatening scenarios for patients in cardiac arrest.

Now, four of Mindray’s BeneHeart series defibrillators have become amongst the first to earn certification under the EU’s tightened MDR controls. This includes three new models that are about to be launched, as well as the already widely used flagship BeneHeart D6.

Under MDR, defibrillators, as a high-energy life-support device, have been up-classified to the highest Class III for direct impact on patients’ internal organs and systems, and thereby a potential risk of further injury or even life threat. This classification requires manufacturers to provide more details of technical documents and clinical evidence, and to go through a conformity assessment conducted by a notified body.

Mindray’s BeneHeart series defibrillators earned accreditation for quality and effectiveness. The devices use mature 360J biphasic technology with automatic impedance compensation, which can significantly reduce the amount of current passing through the heart during defibrillation and reduce the risk of potential damage to myocardial tissue and the patient’s skin. Automatic impedance compensation functionality can also measure impedance of the patient and automatically adjust discharge voltage and discharge time. Mindray’s newly certified defibrillators shorten the whole defibrillation process to 7.5 seconds.

Fast and high-quality defibrillation has been widely recognised for a greater chance of resuscitation success and effective reduction of the myocardial tissue damage.

For more information, visit: www.mindray.com

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