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"Instrument Laboratory" Gem 5000 blood gas analysis system - Taiwan Registration eaaabcf89ed22e60876c268f1419f940

Access comprehensive regulatory information for "Instrument Laboratory" Gem 5000 blood gas analysis system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number eaaabcf89ed22e60876c268f1419f940 and manufactured by INSTRUMENTATION LABORATORY CO.. The authorized representative in Taiwan is Werfen Taiwan Limited.

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eaaabcf89ed22e60876c268f1419f940
Registration Details
Taiwan FDA Registration: eaaabcf89ed22e60876c268f1419f940
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Device Details

"Instrument Laboratory" Gem 5000 blood gas analysis system
TW: "ๅ„€ๅ™จๅฏฆ้ฉ—ๅฎค" ๅฏถ็Ÿณ5000่ก€ๆถฒๆฐฃ้ซ”ๅˆ†ๆž็ณป็ตฑ
Risk Class 2

Registration Details

eaaabcf89ed22e60876c268f1419f940

DHA05603586402

Company Information

United States

Product Details

The GEM Premier 5000 is a portable critical care system that allows professionals to rapidly analyze heparinylated whole blood samples at the time of healthcare delivery in a clinical setting and central laboratory. The instrument quantitatively measures pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactic acid, hematocrit, total bilirubin and CO oxygen saturation (tHb, O2Hb, COHb, MetHb, HHb, sO2) parameters.

A Clinical chemistry and clinical toxicology

A.1120 ่ก€ๅ…งๆฐฃ้ซ”(PCO2,PO2)ๅŠ่ก€ๆถฒpHๅ€ผ่ฉฆ้ฉ—็ณป็ตฑ

Input;; QMS/QSD

Dates and Status

Oct 18, 2022

Oct 18, 2027