Transcription of EU declaration of conformity - Amazon Web Services
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EU declaration of conformity - Amazon Web Services
As per Annex VI of Directive 2014/53/EU Radio Equipment Directive (RED)EU declaration of : MED EL Elektromedizinische Ger te GmbHAddress: F rstenweg 77a, A 6020 Innsbruck, AustriaWe declare on our sole responsibility, that the following product:Product: OPUS 2 (audio processor) and FineTuner (remote control)Description: Audio processor for cochlear implant including an inductive remote control receiveris in compliance with the essential requirements of directive 2014/53/EU (RED) as follows: Essential requirement Article (a) health and safety: Applied Standard(s) or other means of providing conformity : EN 60601 1:2006 + A1:2013 EN 45502 1:1997, EN 45502 2 3:2010 Essential requirement Article (b) electromagnetic compatibility (EMC): Applied Standard(s) or other means of providing conformity : EN 60601 1 2:2007 Essential requirement Article efficient use of radio frequency spectrum: Applied Standard(s) or other means of providing conformity : ETSI EN 300 330:2017 ( ) ETSI EN 302 195:2016 ( )Other Union harmonization legislation (where applicable):In addition, these devices fall into the D
As per Annex VI of Directive 2014/53/EU “Radio Equipment Directive” (RED) EU declaration of conformity AW117890_3.0 Manufacturer: MED‑EL Elektromedizinische Geräte GmbH
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