Taiwan FDA registration ea0f027c04d376bed28be09f3236af03

ICEN 100 Urine Chemistry Analyzer (Unsterilized)

TW: 愛肯100 尿液化學分析儀(未滅菌)
Taiwan flagTaiwan·Risk Class 1·IRIS DIAGNOSTICS·Registered May 28, 2008 – May 28, 2018Cancelled
Registration details
Analysis ID
ea0f027c04d376bed28be09f3236af03
Customs Code
DHA04400676705
Company information
Manufacturer
IRIS DIAGNOSTICS
Manufacturer Country
United States
Product details
Intended Use
Limited to the first level identification range of the "Automatic Urinalysis System (A.2900)" of the Measures for the Administration of Medical Devices.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.2900 Automated urinalysis system
Import Information
import
Dates and status
Registration Date
May 28, 2008
Expiry Date
May 28, 2018
Cancellation Date
Dec 13, 2019
Cancellation information
Status
Logged out
Reason
許可證已逾有效期
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About this record

Access comprehensive regulatory information for ICEN 100 Urine Chemistry Analyzer (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number ea0f027c04d376bed28be09f3236af03 and manufactured by IRIS DIAGNOSTICS. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL, INC., 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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