Pressreleaser | 3 May 2023 | Arcoma

Arcoma AB has received certification according to MDR (MAR)

2023-05-03

PRESSRELEASE

Arcoma AB has received certification according to MDR (MAR)

We are proud to announce that Arcoma AB has received certification according to MDR (regulation EU 2017/745). Arcoma’s product range of Precision i5 and Intuition are therefore fully compatible with the EU regulations for medical devices.

The new EU regulations MDR, Medical Device Regulation, which began to be applied in 2021, is a comprehensive change to the regulations for medical devices. The requirement for MDR certification guarantees that the medical devices used in healthcare are safe.

”Certification according to the MDR is an incredibly important milestone for us, it is proof that our products are safe and live up to the high standards required for medical equipment. The certification is very important for us as a company, for our customers and not least for the patients’ safety”, says Henrik Blomdahl, Quality Manager Arcoma AB.

”I am really happy that the certification has gone through and would like to thank everyone in the organization led by Henrik who have contributed to this success,” says Mattias Leire, CEO Arcoma AB

About Arcoma

Arcoma, with long experience in the industry, is a leading provider of integrated digital X-ray systems with high quality and advanced technology. Arcoma’s products offer the latest digital imaging technology combined with technically advanced moving positioning systems and ergonomic Scandinavian design. Arcoma offers the customers complete, configurable and functional digital x-ray systems. The company’s products are sold through retailers as well as OEM customers and today there are over 3,500 of Arcoma’s X-ray systems installed worldwide. Arcoma is listed on Nasdaq First North. For more information about Arcoma, please visit www.arcoma.se

For more information, please contact:

Henrik Blomdahl, Manager Quality and Regulatory, henrik.blomdahl@arcoma.se , +46 470-706922.
Mattias Leire, VD, mattias.leire@arcoma.se , +46 766-66 54 88
The information was submitted, through the CEO, for publication on May 3rd, 2023 at 10.20 PM.

For more IR-related information and the possibility of pressrelease prenumeration, please visit our IR page: www.arcoma.se/about-us/investors/

This information is such information that Arcoma AB is obliged to publish in accordance with the EU Market Abuse Regulation (MAR). The information was submitted, through the CEO, for publication on May 3rd , 2023 at 10.20 PM.