Taiwan FDA registration 8b58a0008c43500e377b74a3a1cd383c
"Peisi" automatic auditory brainstem response screening instrument
TW: “沛思”自動聽性腦幹反應篩檢儀
Taiwan·Risk Class 2·PATH MEDICAL GMBH·Registered Apr 25, 2024 – Apr 25, 2029ActiveRegistration details
- Analysis ID
- 8b58a0008c43500e377b74a3a1cd383c
- Customs Code
- DHA05603715203
Company information
- Manufacturer
- PATH MEDICAL GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- FORMOSA MEDICAL INSTRUMENTS CO., LTD.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- K Neuroscience;; G Otolaryngology
- Product Type (Level 2)
- G.1050 聽力檢查計;; K.1900 誘發反應聲刺激器
- Import Information
- import
Dates and status
- Registration Date
- Apr 25, 2024
- Expiry Date
- Apr 25, 2029
About this record
Access comprehensive regulatory information for "Peisi" automatic auditory brainstem response screening instrument in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8b58a0008c43500e377b74a3a1cd383c and manufactured by PATH MEDICAL GMBH. The authorized representative in Taiwan is FORMOSA MEDICAL INSTRUMENTS CO., LTD..
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