No, biosignalsplux is not a medical device. biosignalsplux is certified as an electronic device with intended use for life science research and educational purposes.
It is in compliance with the essential requirements of the following directives, if applied in accordance with the manufacturer’s specifications and instructions:
- Radio Equipment Directive 2014/53/EU Article 3.1(a) Safety and Health Standards
- Radio Equipment Directive 2014/53/EU Article 3.1(b) Electromagnetic Compatibility
- Radio Equipment Directive 2014/53/EU Article 3.2. Efficient Use of Spectrum Standards
- RoHS Directive 2011/65/EU
- Human Exposure EMF EN 62311 (2008)
- EMC EN 60601-1-2 (2015)
You can find the Declarations of Conformity for biosignalsplux devices below for regulatory purposes.
Find out more in our regulatory disclaimer.
Declaration of Conformity: 4-Channel & 8-Channel Hubs
4-Channel biosignalsplux hubs are included in the following kits:
- biosignalsplux Explorer
- biosignalsplux ergoExplorer (Discontinued)
- biosignalsplux Force
- biosignalsplux Force+EMG (Discontinued)
- respiBAN Researcher / Professional
- FNIRS Explorer
8-Channel biosignalsplux hubs are included in the following kits:
- biosignalsplux Researcher
- biosignalsplux Professional
- biosignalsplux ergoResearcher (Discontinued)
Declaration of Conformity: openBAN (biosignalsplux Solo)
The openBAN is included in the biosignalsplux Solo kit.