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Declaration of conformity
Unitron Hearing declares under its sole responsibility
that uDirect is in conformity with the following
standards or other standardizing documents:
Radio: EN 300-330
EN 300 328
EMC: EN 60601-1-2
Safety: EN/IEC 60601-1
Implementing the provisions of the MDD 93/42/EEC
(Medical Device Directive), R&TTE Directive 1999/5/EC
(Radio and Telecommunications Terminal Equipment),
EMC Directive 2004/108/EC (Electromagnetic
Compatibility) and LVD 2006/95/EC (Low Voltage
Directive).
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