Taiwan FDA registration 9a176e2c9af3aa8a6faae56439a37fad

"Outomec" audiometer (unsterilized)

TW: "奧圖美" 聽力檢查計(未滅菌)
Taiwan flagTaiwan·Risk Class 1·OTOVATION, LLC·Registered Feb 09, 2011 – Feb 09, 2021Cancelled
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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