Taiwan FDA registration 9f3aa40c89d2f91ead044f9d2bf3436b

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·FIRSTEP BIORESEARCH INC.·Registered Dec 12, 2018 – Dec 12, 2023Expired
Registration details
Analysis ID
9f3aa40c89d2f91ead044f9d2bf3436b
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
國產;; 委託製造;; QMS/QSD
Dates and status
Registration Date
Dec 12, 2018
Expiry Date
Dec 12, 2023
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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 9f3aa40c89d2f91ead044f9d2bf3436b and manufactured by FIRSTEP BIORESEARCH INC.. 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 ProCante Biotechnology Co., Ltd.; Asia Genomics Technology Co., Ltd. Factory 1, 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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