The products are in compliance with the following regulatory
requirements:
•
In EU: The device conforms to the Essential Requirements according to Annex I of Council Directive
93/42/EEC for medical devices (MDD).
•
Hereby, Beltone A/S declares that the radio equipment types CAR46A, CAR12A and 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.beltone.com/declarations.
•
In US: FCC CFR 47 Part 15, subpart C
•
Other identified applicable international regulatory requirements in countries outside the EU and US.
Please refer to local country requirements for these areas.
•
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).
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Regulatory information
