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"Ephry" diaphragmatic rhythm system - Taiwan Registration f668787319540fb0265eb729b3cc6827

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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f668787319540fb0265eb729b3cc6827
Registration Details
Taiwan FDA Registration: f668787319540fb0265eb729b3cc6827
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Device Details

"Ephry" diaphragmatic rhythm system
TW: โ€œ่‰พ่Š™็‘žโ€ๆฉซ่†ˆ็ฏ€ๅพ‹็ณป็ตฑ
Risk Class 3

Registration Details

f668787319540fb0265eb729b3cc6827

DHA05603580104

Company Information

United States

Product Details

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.

K Neuroscience

K.5830 Implantable diaphragm/diaphragm nerve stimulator

Import;; Safety monitoring

Dates and Status

Aug 09, 2022

Aug 09, 2027