Certif icate Quality Assurance

ecm, Bismarckstr. l 06, 52066 Aachen hereby declares that an examination of the under mentioned quality assurance system has been carried out following the requirements of DIN EN ISO 13485:2010.

Through an audit performed on behalf of

RM te me na GmbH Mittelhöfer Str. l, D-34587 Felsberg -Gensungen , Germany

it could be demonstrated that a quality assurance system

according to

for the

DIN EN ISO 13485:2010 "Medical devices - Quality management systems -Requirements for regulatory purposes "

development, manufacture and distribution of single use devices

has been established and implemented .

This certif i cate is only valid under the conditions stated in the hereafter mentioned audit report. Any substantial changes of the quality assurance have to be notified to ECM and are subject to a separate assessment .

Date of initial certification : September 7 '" , 2003 September 25 '" , 2011 Date of prolongation:

Report Number

007-11-811

Registered under

Z/11/02575

Valid until

September 25 '" , 2016

Aachen, September 26 " , 2011

* * * * * Akkreditiert durch * * Zentralstelle der Länder * llLC * fü r G~~~~i~~~~n~~ * * und Medizinprodukten * * * * * ZLG-ZQ-052.05.01-46

~ecm