For occupational therapy, rehab technology and clinical settings
The IntegraMouse AIR is certified as a Class I medical device and approved for use in healthcare settings. Here you'll find the key information for procurement and clinical use.
Certification
Class I medical device under the EU MDR, conformity valid until 01 December 2030. Details under Certification & Safety.
Hygiene in clinical use
In clinical settings, the mouthpiece, membrane, silicone tip and lip switches must be treated as single-use items – never shared between users. Safety testing at least every 24 months (EN 62353:2015).
Procurement
Contact a specialist retailer in your region for the datasheet, trial provision and support with cost coverage.