Taiwan FDA registration 516f56c347b08a0837924fb1f91d7b3e

"Xinkehua" Tecon Automatic Enzyme Immunity Analyzer (Unsterilized)

TW: “新科化”提肯全自動酵素免疫分析儀(未滅菌)
Taiwan flagTaiwan·Risk Class 1·TECAN SCHWEIZ AG·Registered Jun 05, 2012 – Jun 05, 2022Cancelled
Registration details
Analysis ID
516f56c347b08a0837924fb1f91d7b3e
Customs Code
DHA04401179007
Company information
Manufacturer
TECAN SCHWEIZ AG
Manufacturer Country
Switzerland
Authorized Representative
NEW SCIENTIFIC EQUIPMENT CO., LTD.
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
Jun 05, 2012
Expiry Date
Jun 05, 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 "Xinkehua" Tecon Automatic Enzyme Immunity 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 516f56c347b08a0837924fb1f91d7b3e and manufactured by TECAN SCHWEIZ AG. The authorized representative in Taiwan is NEW SCIENTIFIC EQUIPMENT CO., LTD..

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