Taiwan FDA registration 445e26f6e757eda5bdca17643d95d9bf
"Aulympia" cooling cap system
TW: “澳林媲亞”冷卻帽系統
Taiwan·Risk Class 3·Natus Medical Incorporated.·Registered Aug 09, 2010 – Aug 09, 2025ExpiredRegistration details
- Analysis ID
- 445e26f6e757eda5bdca17643d95d9bf
- Customs Code
- DHA00602139401
Company information
- Manufacturer
- Natus Medical Incorporated.
- Manufacturer Country
- United States
- Authorized Representative
- WISDOM UNION ENTERPRISE CO., LTD.
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- K Neuroscience
- Import Information
- import
Dates and status
- Registration Date
- Aug 09, 2010
- Expiry Date
- Aug 09, 2025
About this record
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..
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