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PRESS RELEASE: neoplas med GmbH receives important MDR certificate and strengthens its global pioneering role for cold plasma applications

 

Greifswald, 03 April, 2024 – neoplas med GmbH, the leading company in the field of cold plasma jet medical technology, is very pleased to announce that the innovative Plasmajet kINPen® MED has received the coveted MDR (Medical Device Regulation) certificate for Europe. This certificate confirms the conformity of our product with the strict requirements of the Medical Device Regulation (MDR) and emphasises our commitment to safety and quality in the healthcare sector. neoplas med is thus further expanding its global pioneering role in the establishment of medical cold plasma therapy.

The Plasmajet kINPen® MED has been described in more than 300 scientific publications in prestigious specialist journals, making it the best-documented cold plasma system in the world. Its outstanding significance, due to its superior clinical efficacy in the treatment of infected, acute and chronic wounds, as well as pathogen-related skin diseases, has been proven by randomised, controlled studies in the JAMA journal and Nature Scientific Reports.

With this certification, neoplas med is one of the 10% of MedTech companies in Europe that are MDR-certified. The introduction of the Medical Device Regulation in 2021 marks a significant step in the regulation of medical devices in Europe. Achieving the MDR certificate is an important milestone for the company and confirms the high quality and reliability of the kINPen® MED. “We are proud to be able to make our contribution to improving medical care and are delighted to now be able to make our product available to even broader patient groups internationally,” said Ulrike Sailer, Managing Partner of neoplas med GmbH.
“The MDR certification is not only a recognition of our work to date, but also the basis for continuously developing product innovations and new medical indications (e.g. in ophthalmology, dentology and tumour therapy),” added Sailer.
The ground-breaking cold plasma jet technology can improve the quality of life of patients worldwide.

About neoplas med GmbH: neoplas med from Greifswald in Mecklenburg-Western Pomerania is the leading company in the field of cold plasma jet medical technology, specialising in the development of innovative solutions for the treatment of chronic and acutely infected wounds. The company is a spin-off from the Leibnitz Institute for Plasma Research and Technology in Greifswald. It is known for its kINPen® MED plasma jet, which is recognised worldwide as the best-documented jet plasma system for these applications.

Press contact
Ulrike Sailer
neoplas med GmbH
contact@neoplas-med.eu
+49 3834 515-211