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CE Mark

The SilverCloud Platform is CE marked as a class 1 medical device under the Regulations (EU) 2017/745 MDR, Annex VIII

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CE Mark Intended Use:
The intended purpose of the SilverCloud Platform is for use as an internet-based Cognitive Behavioural Therapy (iCBT) to help adults and children manage their mental health and well-being. The SilverCloud platform is designed to alleviate the signs and symptoms of depression, anxiety, and other mental health conditions. The platform includes various programmes and modules intended to be used with a trained professional to support and monitor the user's progress.
Name & Address of Manufacturer American Well Corporation Limited Ireland,
One Stephens Street Upper,
Dublin 8
Ireland

SilverCloud Health Australia Pty Ltd.
Southport Street
West Leederville
WA 6007
Australia
Type reference SCH-001
Lot number SCH-001 VER. 1.0
March 2017
UDI GTIN: 5391543850005
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