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Doc Number: I-FF-ECDOC Rev L

EC Declaration of Conformity

Manufacturer: Connexicon Medical Ltd.

Synergy Building,

Tallaght lT,

Dublin 24,

Republic of lreland

Name of Device: lndermil flexifuze - Topical Tissue Adhesive, Product Code CM001, Class lla (a per
Rule 4, lndent 3, Annex lX MDD 93l42lEEC\

Ithe undersigned on behalf of Connexicon Medical, hereby declare under our sole responsibility that
the medical device specified above conforms fully with the essential requirements listed in Annex I

and with requirement of Annex V and Annex Vll of EC directive 93/42(EEC (and their transpositions
into National laws in states where the device is intended to be placed on the market) and their
subsequent amendments including Directive 2007 I 47 / EC

This declaration is supported by

o EC Certificate No. G2 15 08 92007 001 (Valid from: 4th Dec 2015 until 3'd Dec 2020)
and
o Certificate of Registration of Quality Management System to EN ISO t3485:20L2,
Certificate Registration No. Q2N 15 08 92007 OOZ @th Dec 2015 until 3'd Dec 2018)

The approving Notified Body is TUV SUD Product Service GmbH, Zertifizierstelle, RidlerstraBe 65,
80339 Mirnchen, Germany (Notified Body number 0123).

signed g aate s6 lDec- l-Uo|

^l-,r[":-
Director of Q&RA