← Back to catalogue
Qalm Fr/It/De/Nl
EUDAMEDClass IIa (EU MDR)
Ref K-QALM- FR/IT/DE/NL
by TensCare Ltd
Identity
- Trade Name
- QALM FR/IT/DE/NL EUDAMED
- Device Name
- Mynd EUDAMED
- Model / Reference
- K-QALM- FR/IT/DE/NL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435139675 EUDAMED
- Basic UDI-DI
- 5033435K00122ZD EUDAMED
- EMDN Code
- Z120622 MUSCLE STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa 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
Qalm Fr/It/De/Nl 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 | 5033435K00122ZD | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- UK-PR-000039358
Sources (1)
- EUDAMED ffd3193f-221e-4865-9431-e5aa2120c47f 61 fields · synced Jun 18, 2026