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CERTIFICATES

ELUTAX SV | Aachen Resonance Holding AG | AR Baltic Medical | Europe

CE-CERTIFICATES ELUTAX "3"

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Free Sales Certificate - Ukraine 

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ISO-13485-2016

Validity of MDD certificate during MDR transition

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Intended use (in Ukraine)

The ELUTAX “3” family of paclitaxel-coated balloon catheters is intended for the

treatment of atherosclerotic or fibrotic strictures in hollow organs - vascular, ureter, urethra and biliary.

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The device achieves its intended therapeutic effect by mechanical dilatation of the stenosed lumen

and local drug delivery using a balloon coated with 2.2 μg/mm² Paclitaxel and 0.7 μg/mm² Dextran,

serving as a hydrophilic excipient.

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outside Ukraine intended use depends on national registrations and can be different.

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CE-Certificates VIAR

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©2021  by AR Baltic Medical LLC, Company Registry 44249274 

All Rights Reserved.This website provides general product information for healthcare professionals only. 

It is not an offer for sale in any jurisdiction. Availability and authorized indications vary by country. Regulatory Note:

This website provides general information only and is not a substitute for official product labeling. Local authorization and approved labeling prevail.

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