Is the Mysa acupressure mat a medical device? Class I CE, EUDAMED
The Mysa acupressure mat is a medical device: what it means and how to verify it
Yes. The Mysa acupressure mat is a Class I medical device with CE marking under European Regulation 2017/745 (MDR). It is registered in the European EUDAMED database (GMDN nomenclature 35503).
No other manufacturer of acupressure mats declares an equivalent registration.
Mysa is the only one
You read that right: there is no other fabric acupressure product recognised as a medical device in the European Union. We never needed certificates: the confirmation comes every day from the people who use it, and nobody knows what an acupressure mat is better than those who invented it in its modern form. But we understand how much an official attestation weighs for you when you choose between the authentic Mysa and a copy that cannot claim any of this.
What "Class I medical device" means
The European Medical Device Regulation (MDR 2017/745) divides devices into four risk classes: I, IIa, IIb, III. Class I covers low-risk, non-invasive devices: an acupressure mat, a cervical collar, a walking stick.
What the manufacturer has to do to obtain it
- Define a medical intended purpose
- Draw up the technical documentation, with assessment of risks and materials (biocompatibility, non-toxicity)
- Demonstrate safety and performance with clinical data
- Register as an economic operator and register the device in EUDAMED
- Apply the CE marking and carry out post-market surveillance
A “wellness” product without this registration cannot claim a medical intended purpose.
What changes for you
| Class I CE medical device (Mysa) | Unregistered wellness product | |
|---|---|---|
| Intended purpose | Declared and documented (musculoskeletal pain, relaxation) | Cannot be declared in medical terms |
| Materials | Assessed for biocompatibility and non-toxicity | At the manufacturer’s discretion |
| Evidence | Clinical data required; for Mysa, the 2021 Padua study | Not required |
| Traceability | Manufacturer registered in EUDAMED, responsible for post-market surveillance | No obligation |
How to verify it
On the packaging and in the manual you will find the CE symbol, the MD symbol (medical device) and the name of the manufacturer.
The European EUDAMED database can be consulted publicly: the Mysa mat is classified under GMDN code 35503. CE marking and EUDAMED registration are valid throughout the European Union; in the UK, CE marking continues to be recognised for medical devices under the current transitional arrangements.
What the registration does not say
Class I certifies safety, materials, traceability and a documented intended purpose; it is not a judgement of effectiveness for every condition.
Effectiveness is on the page what the research says: chronic low back and neck pain, relaxation, sleep, microcirculation. For fibromyalgia, cellulite, herniated discs and other conditions, the reported benefits are user experience.
By Annika, Mysa · Updated 6 November 2026
Frequently asked questions
Is the acupressure mat a medical device?
The Mysa mat is: Class I CE, MDR 2017/745, registered in EUDAMED (GMDN 35503).
Are all acupressure mats medical devices?
No. No other manufacturer declares an equivalent registration; most are sold as wellness products.
Is it covered by health insurance?
No: CE marking certifies safety and medical intended purpose; it does not imply reimbursement by health services or insurers.
Is the registration valid across Europe?
Yes: CE marking and EUDAMED registration are valid throughout the European Union.
