Taiwan FDA registration 84d8e443d7cc7d226faadb39760ca165

"Kaijie" Danex Diess Automatic enzyme immunoassay analyzer (unsterilized)

TW: "凱杰" 丹耐克斯迪斯 全自動酵素免疫分析儀 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·DYNEX TECHNOLOGIES INC.·Registered Aug 24, 2017 – Aug 24, 2022Cancelled
Registration details
Analysis ID
84d8e443d7cc7d226faadb39760ca165
Customs Code
DHA09401823507
Company information
Manufacturer Country
United States
Authorized Representative
QIAGEN TAIWAN COMPANY LIMITED
Product details
Intended Use
Limited to the first level identification range of enzyme analyzer for clinical use (A.2500) of the Measures for the Administration of Medical Devices.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.2500 Enzyme analyzer for clinical use
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Aug 24, 2017
Expiry Date
Aug 24, 2022
Cancellation Date
Sep 30, 2021
Cancellation information
Status
Logged out
Reason
轉為登錄字號
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About this record

Access comprehensive regulatory information for "Kaijie" Danex Diess Automatic enzyme immunoassay analyzer (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 84d8e443d7cc7d226faadb39760ca165 and manufactured by DYNEX TECHNOLOGIES INC.. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.

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