Taiwan FDA registration c3039690fee45fb28d9b75b8f1961282

Ekenvirasti Urinalysis System (Unsterilized)

TW: 愛肯維拉斯提尿液化學分析系統(未滅菌)
Taiwan flagTaiwan·Risk Class 1·IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL, INC.·Registered Oct 01, 2021 – Oct 31, 2023Cancelled
Registration details
Analysis ID
c3039690fee45fb28d9b75b8f1961282
Customs Code
DHA08401873100
Company information
Manufacturer Country
United States
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
Input;; QMS/QSD
Dates and status
Registration Date
Oct 01, 2021
Expiry Date
Oct 31, 2023
Cancellation Date
Nov 02, 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 Ekenvirasti Urinalysis System (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number c3039690fee45fb28d9b75b8f1961282 and manufactured by IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL, INC.. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).

This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including BECKMAN COULTER, INC., IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL, INC., and 4 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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