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The products are in compliance with the following regulatory requirements:
•
In the EU: The device conforms to the General Safety and Performance Requirements according to Annex I
of the EU Medical Device Regulation 2017/745 (MDR).
•
Beltone A/S hereby declares that the radio equipment types CARR1 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.beltone.com/declarations.
•
In the US: FCC CFR 47 Part 15, subpart C.
•
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).
•
For other international regulatory requirements, please refer to the regulatory requirements of the specific
country.
Type designations
Hearing aid type designations for models included in this user guide are:
CARR1, FCC ID: X26CARR1, IC: 6941C-CARR1.
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Regulatory information
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