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"Aulympia" cooling cap system - Taiwan Registration 445e26f6e757eda5bdca17643d95d9bf

Access comprehensive regulatory information for "Aulympia" cooling cap system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 445e26f6e757eda5bdca17643d95d9bf and manufactured by Natus Medical Incorporated.. The authorized representative in Taiwan is WISDOM UNION ENTERPRISE CO., LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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445e26f6e757eda5bdca17643d95d9bf
Registration Details
Taiwan FDA Registration: 445e26f6e757eda5bdca17643d95d9bf
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Device Details

"Aulympia" cooling cap system
TW: โ€œๆพณๆž—ๅชฒไบžโ€ๅ†ทๅปๅธฝ็ณป็ตฑ
Risk Class 3

Registration Details

445e26f6e757eda5bdca17643d95d9bf

DHA00602139401

Company Information

United States

Product Details

It is indicated for use in term infants with clinical signs of moderate to severe ischemic encephalopathy (HIE). The system provides head cooling therapy accompanied by systemic hypothermia therapy to avoid or reduce serious nerve damage in HIE patients.

K Neuroscience

import

Dates and Status

Aug 09, 2010

Aug 09, 2025