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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/tra
nslations/en/renditions/pdf
EC Declaration of Conformity
EasyMed lnstruments Co., 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 organization to use the CE 0197 marking on this product.
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