Declaration of Conformity
Declaration of Conformity
Declaration of Conformity
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Document Number: 2100146 Plant/Division: S&HR<br />
Document Type: REG Version: 00<br />
Page 1 <strong>of</strong> 2<br />
<strong>Declaration</strong> <strong>of</strong> <strong>Conformity</strong><br />
We, declare under our sole responsibility that the product(s) listed below to which this<br />
declaration relates are in conformity with the applicable provisions <strong>of</strong> Directive 93/42/EEC <strong>of</strong><br />
14 June 1993, concerning medical devices.<br />
Manufacturer:<br />
Respironics, Inc.<br />
1001 Murry Ridge Lane<br />
Murrysville, PA 15668-8550 USA<br />
Tel: 800-345-6443<br />
Notified Body:<br />
TÜV SÜD Product Service GmbH<br />
Number 0123<br />
Product Category:<br />
Part Number(s) and<br />
Brief Description:<br />
European Representative:<br />
Respironics Deutschland<br />
Gewerbestrasse 17<br />
82211 Herrsching, Germany<br />
Tel: +49 8152 93060<br />
ComfortGel Full Face Mask<br />
ComfortGel Full SE Face Mask<br />
<strong>Conformity</strong> is Declared to:<br />
Annex I Essential Requirements<br />
Annex II Full Quality Assurance System<br />
1040140 ComfortGel Full Face Mask, Small, International<br />
1040141 ComfortGel Full Face Mask, Medium, International<br />
1040142 ComfortGel Full Face Mask, Large, International<br />
1043550 ComfortGel Full SE Face Mask, Small, International<br />
1043551 ComfortGel Full SE Face Mask, Medium, International<br />
1043552 ComfortGel Full SE Face Mask, Large, International<br />
1054295 ComfortGel Full Face Mask, Launch Intro Kit, Small,<br />
International<br />
1054367 ComfortGel Full Face Mask, Launch Intro Kit,<br />
Medium, International<br />
1054368 ComfortGel Full Face Mask, Launch Intro Kit, Large,<br />
International<br />
1054369 ComfortGel Full Face Mask, DuoPack with Headgear,<br />
Small, International<br />
1054370 ComfortGel Full Face Mask, DuoPack with Headgear,<br />
Medium, International<br />
1054371 ComfortGel Full Face Mask, DuoPack with Headgear,<br />
Large, International<br />
Product Classification: IIa Classification<br />
Rule:<br />
Harmonized<br />
Standards:<br />
EN ISO 13485 EN ISO 14971 EN ISO 10993-1<br />
This document is created using the Form information listed below.<br />
Document Number: 1215 Plant/Division: Homecare<br />
Document Type: FR Version: 03<br />
2
Document Number: 2100146 Plant/Division: S&HR<br />
Document Type: REG Version: 00<br />
Page 2 <strong>of</strong> 2<br />
Range <strong>of</strong> Control<br />
Numbers for Product<br />
(if applicable):<br />
Approved By:<br />
(signature)<br />
All<br />
David A. Scala<br />
Title: Director, Quality Systems<br />
Sleep and Home Respiratory Group<br />
June 13, 2008<br />
This document is created using the Form information listed below.<br />
Document Number: 1215 Plant/Division: SHR<br />
Document Type: FR Version: 03
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