EQS-News: Viromed Medical AG: Successful ISO 13485 certification paves the way for market launch of ViroCAP® in October 2025

Viromed Medical AG: Successful ISO 13485 certification paves the way for market launch of ViroCAP® in October 2025

Rellingen, September 18, 2025 – Viromed Medical AG ("Viromed"; ISIN: DE000A3MQR65), a medical technology company and pioneer of cold plasma technology, has received the ISO 13485 certification. This officially makes Viromed a medical device manufacturer, paving the way for the company to launch its own medical devices on the market. Viromed can now independently approve and market ViroCAP®, a mobile medical device for the treatment of skin diseases. Sales and deliveries of the first devices in the ViroCAP® product family will begin in October 2025.

Uwe Perbandt, CEO of Viromed Medical AG, explains: "With this certification, we have reached the next milestone. We are no longer just a developer, but also an approved manufacturer, enabling us to bring our products to market independently and quickly. This not only opens up new revenue potential for us, but also gives us a clear competitive advantage. We expect the introduction of our ViroCAP® systems to provide a strong boost to our growth and the expansion of our market position."

The ISO 13485 certification is a key requirement for the approval of medical devices in Europe in accordance with the applicable Medical Device Regulation (MDR). It certifies that Viromed has successfully established a quality management system in accordance with international standards. With this successful certification, the company has laid the foundation for accelerated market launch of its products – and thus for sustainable revenue growth.

Wide range of product for different fields of application

With the ViroCAP® product range, Viromed addresses several markets. ViroCAP® derma and ViroCAP® med are intended for use in dermatology and wound treatment, while ViroCAP® vet is intended for veterinary use. Both ViroCAP® derma and ViroCAP® vet can be launched on the market immediately upon receipt of the certificate. At just 160 grams, the ViroCap® is the world's lightest mobile device for cold plasma applications. Its technology enables contact-free treatment, eliminating the need for direct contact with the skin or wound.

With the ability to independently certify class-I-risk products, Viromed gains significant flexibility and speed in market entry. The company is thus tapping into attractive growth areas in dermatology and the clinical environment.

About Viromed Medical AG

Viromed Medical AG specializes in the development, manufacture and distribution of medical products. The operating business of the company, which has been listed on the stock exchange since October 2022, focuses on the distribution of innovative cold plasma technology for medical applications via its wholly owned subsidiary Viromed Medical GmbH. Viromed can draw on a broad customer base in the DACH region and beyond. Viromed is pursuing the goal of further advancing the use of cold plasma technology in medicine in the coming years and realizing the corresponding growth potential.

www.viromed-medical-ag.de

Contact Viromed

E-Mail: kontakt@viromed-medical.de
 

Press contact

E-mail: viromed@kirchhoff.de