Certification & Safety
The IntegraMouse AIR is certified as a Class I medical device under EU MDR (EU) 2017/745 – the only one of its kind among mouth-controlled mice.
Certifications & Conformity
- Class I medical device, EU MDR (EU) 2017/745, Annex VIII Rule 5
- CE marking, UKCA marking, FCC marking (USA), KC-registered under no. R-R-CZ1-IntegraAIR (South Korea)
- CE declaration of conformity valid until 1 December 2030
- GDPR (EU) 2016/679, EMC Directive, Radio Equipment Directive, RoHS and WEEE Directive
Important information
- Suitable for users aged 3 and up
- Not suitable in cases of uncontrolled spasms, Tourette syndrome, epilepsy or excessive salivation
- Must not be used for moving systems, life-supporting equipment or vehicle control
- Detailed safety information is provided in the manual