Certified neurostimulation for treatment in your own home

Re5 Depression Treatment and Re5 Parkinson's Treatment are CE-certified according to EU MDR (2017/745).

The CE certifications are your assurance of effective stimulation treatment that is scientifically substantiated and meets strict European standards for medical devices.

In addition, Re5 is certified according to the international standards ISO 13485 and IEC 60601, ensuring the highest quality in design, manufacturing and safety for medical devices. 

Depression

Parkinson’s

Clinical evidence

How it works

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Depression

Parkinson’s

Clinical evidence

How it works

Legal & regulatory

Privacy policy

Terms and conditions

Impressum

COMPANY

Re5 ApS

Niels Ebbesens Vej 31

1911 Frederiksberg C Copenhagen, Denmark

E-mail: info@re5.com

© 2026 Re5 Regeneration. All rights reserved.

REGULATORY AND LEGAL NOTICE


Re5 ApS — Danish medical device manufacturer

CE MDR Class IIa | EU MDR 2017/745 | ISO 13485 | IEC 60601

Re5 is a registered medical device manufacturer in the EU. This website and its content are produced in accordance with EU MDR 2017/745 and applicable Danish medical device advertising regulations. For regulatory enquiries or to request clinical documentation, contact us directly.

This website is intended for healthcare professionals and institutional decision-makers. Some illustrative images are AI-generated. All clinical claims are supported by clinical data, including peer-reviewed scientific literature, as documented in the Clinical Evaluation Report prepared in accordance with EU MDR requirements.

Menu

Depression

Parkinson’s

Clinical evidence

How it works

Legal & regulatory

Privacy policy

Terms and conditions

Impressum

COMPANY

Re5 ApS

Niels Ebbesens Vej 31

1911 Frederiksberg C Copenhagen, Denmark

E-mail: info@re5.com

© 2026 Re5 Regeneration. All rights reserved.

REGULATORY AND LEGAL NOTICE


Re5 ApS — Danish medical device manufacturer

CE MDR Class IIa | EU MDR 2017/745 | ISO 13485 | IEC 60601

Re5 is a registered medical device manufacturer in the EU. This website and its content are produced in accordance with EU MDR 2017/745 and applicable Danish medical device advertising regulations. For regulatory enquiries or to request clinical documentation, contact us directly.

This website is intended for healthcare professionals and institutional decision-makers. Some illustrative images are AI-generated. All clinical claims are supported by clinical data, including peer-reviewed scientific literature, as documented in the Clinical Evaluation Report prepared in accordance with EU MDR requirements.

Menu

Depression

Parkinson’s

Clinical evidence

How it works

Legal & regulatory

Privacy policy

Terms and conditions

Impressum

COMPANY

Re5 ApS

Niels Ebbesens Vej 31

1911 Frederiksberg C Copenhagen, Denmark

E-mail: info@re5.com

© 2026 Re5 Regeneration. All rights reserved.

REGULATORY AND LEGAL NOTICE


Re5 ApS — Danish medical device manufacturer

CE MDR Class IIa | EU MDR 2017/745 | ISO 13485 | IEC 60601

Re5 is a registered medical device manufacturer in the EU. This website and its content are produced in accordance with EU MDR 2017/745 and applicable Danish medical device advertising regulations. For regulatory enquiries or to request clinical documentation, contact us directly.

This website is intended for healthcare professionals and institutional decision-makers. Some illustrative images are AI-generated. All clinical claims are supported by clinical data, including peer-reviewed scientific literature, as documented in the Clinical Evaluation Report prepared in accordance with EU MDR requirements.