The products are in compliance with the following regulatory requirements:
• In EU: The device conforms to the General Safety and Performance Requirements according to AnnexI of
the EU Medical Device Regulation 2017/745 (MDR).
• Hereby, GN ReSound 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.declarations.resound.com.
• 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 63
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