Taiwan FDA registration 9a121e024571a7a6f3f0ee8dca18c50f

"ARKRA" urinalysis tester (unsterilized)

TW: "愛科來" 尿液分析檢測儀 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·ARKRAY INDUSTRY, INC.·Registered Oct 01, 2021 – Oct 31, 2026Active
Registration details
Analysis ID
9a121e024571a7a6f3f0ee8dca18c50f
Customs Code
DHA08401605104
Company information
Manufacturer Country
Philippines
Authorized Representative
SYNGEN BIOTECH CO., LTD.
Product details
Intended Use
Limited to the first level identification range of the "Automated Urinalysis System (A.2900)" 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.2900 Automated urinalysis system
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Oct 01, 2021
Expiry Date
Oct 31, 2026
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About this record

Access comprehensive regulatory information for "ARKRA" urinalysis tester (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 9a121e024571a7a6f3f0ee8dca18c50f and manufactured by ARKRAY INDUSTRY, INC.. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including ARKRAY INDUSTRY, INC., Arkray Factory Inc., Head office factory, and 2 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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