Identity
- Trade Name
- MYND EUDAMED
- Device Name
- Mynd EUDAMED
- Model / Reference
- K-MYND EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435136360 EUDAMED05033435134359 EUDAMED
- Basic UDI-DI
- 5033435K00122DS5 EUDAMED5033435K00122ZD EUDAMED
- EMDN Code
- Z120622 MUSCLE STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Medical Purpose
- MYND is a medical device designed to be used in the home healthcare environment for the treatment and prevention of frequent episodic and chronic migraine headaches. It is suitable for use by all who can control the device and understand the instructions. There is currently no evidence of effectiveness for users under the age of 18. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Mynd by TensCare Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5033435K00122DS5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- GB-MF-000004156
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 4b9fb572-0983-4d5e-9a0b-190b0b1bc039 61 fields · synced Jul 12, 2026
- EUDAMED 6729d3fd-f9ec-4485-a1dc-a1ed1cb3e95c 61 fields · synced May 19, 2026