Taiwan FDA registration 776d494b261c02284014e3a00b0dfb53
"Nexus" diaphragmatic rhythm system
TW: “紐可適”橫膈節律系統
Taiwan·Risk Class 3·Synapse Biomedical Inc.·Registered Nov 17, 2019 – Nov 17, 2029ActiveRegistration details
- Analysis ID
- 776d494b261c02284014e3a00b0dfb53
- Customs Code
- DHA05603297601
Company information
- Manufacturer
- Synapse Biomedical Inc.
- Manufacturer Country
- United States
- Authorized Representative
- MEDLION LIFE SCIENCE TECHNOLOGY COMPANY
Product details
- Intended Use
- Provides respiratory support in patients with neurogenic diaphragmatic dysfunction. Diaphragmatic dysfunction results from high spinal cord injury, central hypoventilation, and amyotrophic lateral sclerosis.
- Product Type (Level 1)
- K Neuroscience
- Product Type (Level 2)
- K.5830 Implantable diaphragm/diaphragm nerve stimulator
- Import Information
- Import;; Safety monitoring
Dates and status
- Registration Date
- Nov 17, 2019
- Expiry Date
- Nov 17, 2029
About this record
Access comprehensive regulatory information for "Nexus" 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 776d494b261c02284014e3a00b0dfb53 and manufactured by Synapse Biomedical Inc.. The authorized representative in Taiwan is MEDLION LIFE SCIENCE TECHNOLOGY COMPANY.
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