Safe depression treatment | CE certified | EU MDR | ISO13485

For a long time, the treatment has been reserved for specialized wards in the country's psychiatric departments. Now the Re5 treatment has been CE certified according to EU MDR (2017/745), which means that we can offer the treatment to many more people.

Find out how to get started here.

CE certification to the EU MDR is your assurance of a safe and effective treatment for depression that is scientifically proven and meets strict European medical device standards.

In addition, Re5 is certified to the international standards ISO 13485 and IEC 60601, ensuring the highest quality in medical device design, manufacturing and safety, so we can offer a depression treatment you can trust.

Re5 depression treatment shows that there is clinical evidence for treating patients with moderate to severe depression. The studies show that after 8 weeks of treatment, more than 60 percent of treated patients achieved complete symptom relief or significant improvement in their condition.

Among those who achieved complete symptom relief, the effect remained in over half of the patients two years after treatment. For those who experienced a relapse, a repeat course of treatment proved highly effective.

Among those who experienced side effects, these were generally mild and transient, including symptoms such as mild nausea or headache, which typically occurred at the beginning of the treatment course. Data from the clinical trials also showed that side effects related to any concomitant antidepressant medication were significantly reduced by treatment.

You can explore the research with Re5 for the treatment of depression below.