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“Instrumentation Laboratory”GEM Premier 4000 Analyzer - Taiwan Registration f03b2b5d1671bd470a6915eda55fe5b7

Access comprehensive regulatory information for “Instrumentation Laboratory”GEM Premier 4000 Analyzer in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f03b2b5d1671bd470a6915eda55fe5b7 and manufactured by INSTRUMENTATION LABORATORY CO.,. The authorized representative in Taiwan is Werfen Taiwan Limited.

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f03b2b5d1671bd470a6915eda55fe5b7
Registration Details
Taiwan FDA Registration: f03b2b5d1671bd470a6915eda55fe5b7
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Device Details

“Instrumentation Laboratory”GEM Premier 4000 Analyzer
TW: “儀器實驗室”寶石 4000 血液氣體分析儀
Risk Class 2
MD

Registration Details

f03b2b5d1671bd470a6915eda55fe5b7

Department of Health Medical Device Import No. 018660

DHA00601866009

Company Information

United States

Product Details

This instrument is a portable intensive care system that provides quantitative values of pH, sodium, potassium, chloride, calcium, glucose, lactate, hematocrit and carbon monoxide-oxygen detector (tHb, O2Hb, COHb, MetHb and HHb).

A Clinical chemistry and clinical toxicology

A1120 Blood gas (PCO2, PO2) and blood pH test system

Imported from abroad

Dates and Status

Nov 02, 2007

Nov 02, 2027