Taiwan FDA registration 946862df50bfb253df7c4de16c302d0e

Analytic portable test strip detector (unsterilized)

TW: 速析能可攜式試紙檢測儀 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·ProCante Biotechnology Co., Ltd.; Asia Genomics Technology Co., Ltd. Factory 1·Registered Mar 30, 2020 – Mar 30, 2025Expired
Registration details
Analysis ID
946862df50bfb253df7c4de16c302d0e
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
Contract manufacturing;; Domestic
Dates and status
Registration Date
Mar 30, 2020
Expiry Date
Mar 30, 2025
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About this record

Access comprehensive regulatory information for Analytic portable 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 946862df50bfb253df7c4de16c302d0e and manufactured by ProCante Biotechnology Co., Ltd.; Asia Genomics Technology Co., Ltd. Factory 1. The authorized representative in Taiwan is POCT BIOTECHNOLOGY CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including FIRSTEP BIORESEARCH INC., and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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