Certificate

EU Declaration of Conformity
rnd doc surgical mask.docx Page 1 of 1
We:
Company name: Distrelec Group AG
Postal address: Enterprise Hub, 7th Floor, 2 St Peter's Square
Postcode and City: Manchester, M2 3AA
E-Mail address [e-mail]
Hereby declare that:
RND ARTICLE NUMBER
RND PRODUCT DESCRIPTION
RND 600-00263
3 ply Surgical Face Mask
Has been manufactured in conformity to the following community Directives/Regulations and Standards:
Council Directive 93/42 / EEC of 14 June 1993 concerning medical devices:
Class I according directive 93/42/EWG Appendix IX; Rule 1
Chosen conformity procedures:
According the Directive 93/42/EEC Appendix VII
Applied standards:
EN ISO 13485:2016 Medical devices – Quality management systems - Requirements for regulatory purposes
(ISO 13485:2016); DIN EN ISO 13485:2016
Signed for and on behalf of:
David Connelly
Senior Quality and Legislation Manager Date 30/09/2020
DoC nr: 2020-00050