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, GN ReSound A/S declares that the radio equipment types , CAR12Aand CAR13A are in compliance
with Directive 2014/53/EU.
•
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 has been
certified 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:
CAR12A
, FCC ID: X26CAR12A, IC: 6941C-CAR12A
CAR13A
, FCC ID: X26CAR13A, IC: 6941C-CAR13A.
Regulatory information
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