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11. Compliance information
Declaration of conformity
Hereby, Sonova AG declares that this product meets the
requirements of the Medical Devices Regulation MDR 2017/745
and complies with Radio Equipment Directive 2014/53/EU. The full
text of the EU Declarations of Conformity can be obtained from the
manufacturer via the following web address:
https://www.hansaton.de/en/declarations-of-conformity.
Australia/New Zealand:
Indicates a device’s compliance with applicable Radio
Spectrum Management’s (RSM) and Australian
Communications and Media Authority (ACMA) regulatory
arrangements for the legal sale in New Zealand and
Australia. The compliance label R-NZ is for radio products
supplied in the New Zealand market under conformity
level A1
Notice 1
This device complies with Part 15 of the FCC Rules and with RSS-
210 of Industry Canada. Operation is subject to the following two
conditions:
1) this device may not cause harmful interference, and
2) this device must accept any interference received, including
interference that may cause undesired operation.
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