The products are in compliance with the following regulatory requirements:
•
In EU: The device conforms to the General Safety and Performance Requirements according to Annex I of
the EU Medical Device Regulation 2017/745 (MDR).
•
Hereby, Beltone A/S declares that the radio equipment type CABR80 is in compliance with Radio Equipment
Directive 2014/53/EU (RED).
•
The full text of the EU declaration of conformity is available at the following internet address:
www.beltone.com/declarations.
•
In the US: FCC CFR 47 Part 15, subpart C.
•
For other international regulatory requirements, please refer to the regulatory requirements of the specific
country.
•
In Canada: these hearing aids are certified under the rules of ISED.
•
Japanese Radio Law and Japanese Telecommunications Business Law Compliance. This device is granted
pursuant to the Japanese Radio Law (
電 波 法
) and the Japanese telecommunications Business Law (
電 気 通
信 事 業 法
). This device should not be modified (otherwise the granted designation number will become
invalid).
Type designations
Hearing aid type designations for models included in this user guide are:
CABR80
, FCC ID: X26CABR80, IC6941C-CABR80.
Regulatory information
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