- is certified to the requirements of EN ISO 13485: 2012 and Annex II (excluding section 4) of the EU Medical Device Directive, and is also registered as Medical Device Manufacturer at the USA Food and Drug Administration.
Jacoti ListenApp is Class I FDA registered Medical Device, classified under product code ESD, and Jacoti Hearing Center and Jacoti Hearing Center Pro are Class II FDA listed Medical Device, classified under product code EWO.
As Medical devices, they are designed, developed and manufactured in accordance with a quality system compliant with 21 CFR Part 820 (United States quality requirements).
The CE mark indicates that Jacoti ListenApp, Jacoti Hearing Center and Jacoti Hearing Center Pro meet the requirements of Annex II (excluding section 4) of the Medical Device Directive 93/42/EEC. This approval is granted by the highly respected Notified Body BSI.
The placing of CE markings on medical devices.
Several rules must be complied with in order to receive a declaration of conformity. These rules relate not to product verification but to the approval of a quality system for design, manufacture and final inspection.