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European Medical Device Regulation requires that any serious incident that has
occurred in relation to this device should be reported to the manufacturer and the
competent authority in your country. This can be found at:
https://ec.europa.eu/docsroom/documents/36683/attachments/1/translations/
EC Declaration of Conformity
Easymed Ltd hereby declare that an examination of the production quality assurance
system has been carried out following the requirements of the UK national legislation
according to Annex V of the Directive 93/42/EEC on medical devices. We certify that
the production quality system conforms with the relevant provisions of the
aforementioned legislation, and the result entitles the organisation to use the CE 0197
marking on this product.