Taiwan FDA registration 8c4faf5abeacc3a6942f67ce1a2e7912
“IHS” Otoacoustic Emission(OAE) Test System
TW: “愛耳斯”耳聲傳射聽力儀
Taiwan·Risk Class 2·MD·INTELLIGENT HEARING SYSTEMS·Registered Oct 18, 2016 – Oct 18, 2026ActiveRegistration details
- Analysis ID
- 8c4faf5abeacc3a6942f67ce1a2e7912
- License Form
- Ministry of Health Medical Device Import No. 028988
- Customs Code
- DHA05602898803
Company information
- Manufacturer
- INTELLIGENT HEARING SYSTEMS
- Manufacturer Country
- United States
- Authorized Representative
- RONAMAC INTERNATIONAL CORP.
Product details
- Intended Use
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- G ENT device
- Product Type (Level 2)
- G1050 Audiogram
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 18, 2016
- Expiry Date
- Oct 18, 2026
About this record
Access comprehensive regulatory information for “IHS” Otoacoustic Emission(OAE) Test System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8c4faf5abeacc3a6942f67ce1a2e7912 and manufactured by INTELLIGENT HEARING SYSTEMS. The authorized representative in Taiwan is RONAMAC INTERNATIONAL CORP..
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