Taiwan FDA registration 11020cedf91c7033b1c9707358214080

Rapid analysis three-channel test strip detector (unsterilized)

TW: 速析能三通道試紙檢測儀 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·ProCante Biotechnology Co., Ltd.; Asia Genomics Technology Co., Ltd. Factory 1·Registered Feb 05, 2021 – Feb 05, 2026Expired
Registration details
Analysis ID
11020cedf91c7033b1c9707358214080
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
POCT BIOTECHNOLOGY CO., LTD.
Product details
Intended Use
Limited to the first level of identification range of "density meter/scanner for clinical use (integration, reflection, thin layer chromolayer or radioactive chromolayer analysis)" (A.2400) of the Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.2400 Density Meter/Sweeper for Clinical Use (Separation, Reflection, Thin Layer or Radioactive Color Layer Analysis)
Import Information
委託製造;; 國產;; QMS/QSD
Dates and status
Registration Date
Feb 05, 2021
Expiry Date
Feb 05, 2026
About this record

Access comprehensive regulatory information for Rapid analysis three-channel test strip detector (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 11020cedf91c7033b1c9707358214080 and manufactured by ProCante Biotechnology Co., Ltd.; Asia Genomics Technology Co., Ltd. Factory 1. The authorized representative in Taiwan is POCT BIOTECHNOLOGY CO., LTD..

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