EC-CERTIFICATE DQS GmbH - CEATEC Medizintechnik
EC-CERTIFICATE DQS GmbH - CEATEC Medizintechnik
EC-CERTIFICATE DQS GmbH - CEATEC Medizintechnik
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<strong>EC</strong>-<strong>CERTIFICATE</strong><br />
<strong>DQS</strong> <strong>GmbH</strong><br />
Deutsche Gesellschaft zur Zertifizierung von Managementsystemen<br />
hereby certifies that the company<br />
CEAT<strong>EC</strong> <strong>Medizintechnik</strong> <strong>GmbH</strong> & Co. KG<br />
Untere Hauptstrasse 6<br />
78573 Wurmlingen<br />
Germany<br />
has implemented and maintains a<br />
Quality Management System<br />
with respect to the aspects of manufacture concerned<br />
with securing and maintaining sterile conditions.<br />
An audit, documented in a report, performed by <strong>DQS</strong><br />
has verified that this quality management system<br />
fulfills the requirements of<br />
Annex V of Directive 93/42/E<strong>EC</strong><br />
with respect to the following medical devices:<br />
surgical disposable products as listed in the annex<br />
As set out in section 4, Annex V, of the said directive, the manufacturer of<br />
these devices is subject to surveillance. The CE-mark with the number of the<br />
notified body may be used on the devices listed in the certificate.<br />
� 0297<br />
This certificate is valid until 2013-10-12<br />
Certificate Registration No. 217466 MR5s<br />
Frankfurt am Main 2009-06-17<br />
Ass. iur. M. Drechsel Dipl.-Bw. J. Böge<br />
MANAGING DIR<strong>EC</strong>TORS<br />
D-60433 Frankfurt am Main, August-Schanz-Straße 21<br />
<strong>EC</strong> code number of <strong>DQS</strong> as notified body: 0297
Annex to Certificate Registration No.: 217466 MR5s<br />
(Edition 2009-06-17)<br />
product categories<br />
CEAT<strong>EC</strong> <strong>Medizintechnik</strong> <strong>GmbH</strong> & Co. KG<br />
Untere Hauptstrasse 6<br />
78573 Wurmlingen<br />
Germany<br />
products<br />
surgical disposable products single use sterile scalpel blades, UMDNS-No. 12-252<br />
and single use scalpels, UMDNS-No. 12-234<br />
This annex (Edition 2009-06-17) is only valid in connection<br />
with the above-mentioned certificate.