Taiwan FDA registration 9a176e2c9af3aa8a6faae56439a37fad
"Outomec" audiometer (unsterilized)
TW: "奧圖美" 聽力檢查計(未滅菌)
Registration details
- Analysis ID
- 9a176e2c9af3aa8a6faae56439a37fad
- Customs Code
- DHA04400990009
Company information
- Manufacturer
- OTOVATION, LLC
- Manufacturer Country
- United States
- Authorized Representative
- MADISON MEDICAL INSTRUMENTS CORP.
Product details
- Intended Use
- Limited to the first-level recognition range of the Measures for the Administration of Medical Devices "Audiogrammeter (G.1050)".
- Product Type (Level 1)
- G ENT Science
- Product Type (Level 2)
- G.1050 Audiometer
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Feb 09, 2011
- Expiry Date
- Feb 09, 2021
- Cancellation Date
- Sep 08, 2023
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for "Outomec" audiometer (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 9a176e2c9af3aa8a6faae56439a37fad and manufactured by OTOVATION, LLC. The authorized representative in Taiwan is MADISON MEDICAL INSTRUMENTS CORP..
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