Taiwan FDA registration a534562894d17162bad6d16e1166803e
"Iris" short-term diaphragmatic rhythm system
TW: “艾瑞絲”短期橫膈節律系統
Taiwan·Risk Class 3·Synapse Biomedical Inc.·Registered Jul 08, 2024 – Jul 08, 2029ActiveRegistration details
- Analysis ID
- a534562894d17162bad6d16e1166803e
- Customs Code
- DHA05603734106
Company information
- Manufacturer
- Synapse Biomedical Inc.
- Manufacturer Country
- United States
- Authorized Representative
- MEDLION LIFE SCIENCE TECHNOLOGY COMPANY
Product details
- Intended Use
- This product is a percutaneous intramuscular diaphragm stimulator for patients at risk or for long-term positive pressure mechanical ventilation. This product is indicated for the prevention and treatment of diaphragmatic dysfunction (VIDD) caused by respirator therapy.
- Product Type (Level 1)
- K Neuroscience
- Product Type (Level 2)
- K.5830 Implantable diaphragm/diaphragm nerve stimulator
- Import Information
- Safety monitoring;; import
Dates and status
- Registration Date
- Jul 08, 2024
- Expiry Date
- Jul 08, 2029
About this record
Access comprehensive regulatory information for "Iris" short-term diaphragmatic rhythm system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number a534562894d17162bad6d16e1166803e and manufactured by Synapse Biomedical Inc.. The authorized representative in Taiwan is MEDLION LIFE SCIENCE TECHNOLOGY COMPANY.
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