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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.

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