Taiwan FDA registration 0431beb96e51931c64edddc170713223

"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 Oct 01, 2021 – Oct 31, 2022Cancelled
Registration details
Analysis ID
0431beb96e51931c64edddc170713223
Customs Code
DHA08401179004
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
Input;; QMS/QSD
Dates and status
Registration Date
Oct 01, 2021
Expiry Date
Oct 31, 2022
Cancellation Date
Feb 01, 2023
Cancellation information
Status
Logged out
Reason
未展延而逾期者
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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 0431beb96e51931c64edddc170713223 and manufactured by TECAN SCHWEIZ AG. The authorized representative in Taiwan is NEW SCIENTIFIC EQUIPMENT CO., LTD..

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