Taiwan FDA registration f668787319540fb0265eb729b3cc6827
"Ephry" diaphragmatic rhythm system
TW: “艾芙瑞”橫膈節律系統
Taiwan·Risk Class 3·AVERY BIOMEDICAL DEVICES, INC.·Registered Aug 09, 2022 – Aug 09, 2027ActiveRegistration details
- Analysis ID
- f668787319540fb0265eb729b3cc6827
- Customs Code
- DHA05603580104
Company information
- Manufacturer
- AVERY BIOMEDICAL DEVICES, INC.
- Manufacturer Country
- United States
- Authorized Representative
- BROJAW INC.
Product details
- Intended Use
- This product is suitable for those who need long-term ventilator assistance due to upper motor neuron respiratory muscle paralysis (RMP) or central hypoventilation syndrome (CAH), and their phrenic nerve, lung and diaphragm function can still accept current stimulation. Candidates for the diaphragmatic rhythmic system include: central hypoventilation syndrome, decreased respiratory ventilation during the day or night (e.g., central sleep apnea), brainstem injury or disease, spinal cord injury or disease.
- 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
- Aug 09, 2022
- Expiry Date
- Aug 09, 2027
About this record
Access comprehensive regulatory information for "Ephry" 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 f668787319540fb0265eb729b3cc6827 and manufactured by AVERY BIOMEDICAL DEVICES, INC.. The authorized representative in Taiwan is BROJAW INC..
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