Quality System Gert¡f¡cateCertificate Number: DGM -6s1

A DNV & NEMKOCOMPANY

This is to certify that the quality system of

Goloplast GmbHKuehnstrasse 7522045 HamburgGermany

fulfills the requirements in

DS/EN ISO 9001 :2008 and DS/EN ISO 13485:2012

The certificate covers the following activities:

Manufacturing, sale and distribution of medical devices. In addition patientcounseling and patient care services related to the supply of medicaldevices and products.

The certificate is valid provided that the quality system continues to conform to the above-mentioned scope and provided that the companydoes not introduce substant¡al changes to the quality system without the approval of Presafe Denmark A/S. Certifications to DS/EN ISO13485:2012, EN ISO 134852012, ISO 13485:2003, DS/EN ISO 9001 : 2008, EN ISO 9001 :2008 and ISO 9001 :2008 include therequirements of the applicable The quality system certificate is issued pursuant to Presafe Denmark A,/S' terms and conditions forthe certification of quality medical devices.

Date of issue:

Expires:

lnitial date of issue

Reference:

201 7-06-06

201 8-09-1 5

2008-10-08

auriso1703v1 10690For

& onrunr

Presafe Denmark AISTuborg ParkvejB

2900 HellerupDenmark

DG5Y5lt¡vl Req No. ¡f'0/

o DGM 2013-08-158L 11.0'0148 v17.0

A/S

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