Elitech NANODUCT 1030 User Manual page 4

© 2020 ELITechGroup Inc. All rights reserved.
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whatsoever, without the prior express written permission of ELITechGroup Inc.
Webster Sweat Inducer™, and Sweat-Chek™, are trademarks of ELITechGroup Inc. Wescor , Pilogel and
® ®
Macroduct are registered trademarks.
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Other trade names used in this manual are trademarks of their respective owners, used here for information
only.
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appropriate use regarding any type of specific procedure. ELITechGroup Inc. may modify this manual without
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Manufactured in the United States of America by:
ELITechGroup Inc.
370 West 1700 South
Logan, Utah 84321-8212 USA
2797
The Notified Body number above signifies that British Standards Institute BSI has certified the Production
Quality Assurance System of ELITechGroup Inc., according to Annex V of the Medical Device Directive 93/42/
EEC (MDD). The scope of that certificate, CE 59518, is:
The manufacture of sweat analysis systems for cystic fibrosis; and sweat inducers (to obtain samples for use in
the subsequent laboratory diagnosis of cystic fibrosis).
This covers the Class IIa devices Macroduct Advanced Model 3710, Macroduct Model 3700, and Nanoduct
Model 1030. Together with the Declaration of Conformity issued by the manufacturer according to Annex VII,
this allows the CE marking of these devices. There are no accessories to which the CE certificate or the BSI
Notified Body Number 2797 applies.