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7. Compliance information
Europe:
Declaration of Conformity
Hereby Sonova AG declares that this product meets the
requirements of the Medical Device Regulation 2017/745
as well as the Radio Equipment Directive 2014/53/EU. The
full text of the EU Declaration of Conformity can be
obtained from the manufacturer or the local Phonak
representative whose address can be taken from the list
on https://www.phonak.com/com/en/certificates.html
(Phonak worldwide locations).
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.
