Eu Mdr Eu Md Class 2a On The Market

QALM FR/IT/DE/NL

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.

Devices (same UDI-DI)
3
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
05033435139675
Basic UDI-DI Code
5033435K00122ZD
Reference
K-QALM- FR/IT/DE/NL
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

QALM 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. This device is only to be applied to the skin on the forehead. Do not use the device for any purpose other than this intended use.

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.

CND Nomenclature Codes

Code Description
Z120622 MUSCLE STIMULATORS

Related Devices

The Basic UDI-DI associated with this device has 3 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Similar Devices

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).

View all