Blood Gas Analyzer, Electrolyte - Vietnam Registration 2402244ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Blood Gas Analyzer, Electrolyte in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2402244ĐKLH/BYT-HTTB and manufactured by Siemens Healthcare Diagnostics Manufacturing Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Diamond Diagnostics Inc, and 5 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
2402244ĐKLH/BYT-HTTB
000.00.04.G18-220426-0009
Rapidlab 348EX System
10844678
Technical Details
The system is designed to determine pH, pCO2, pO2, Na+, K+, Ca++ or Cl– and Hct in the whole blood samples of individuals treated with heparin. The minimum sample volume is 50 μL. The results are displayed on the touch screen according to pH or H+, mmHg or kPa for pCO2 and pO2, mmol/L for Na+, K+, Ca++ or Cl–, and % for Hct. The system also calculates the following parameters: • Standard and actual bicarbonate (HCO3–std and HCO3–act) • Total carbon dioxide content (ctCO2) • Base excess in blood and interstitial fluid (BE(B) and BE(ecf)) • Estimated oxygen saturation (O2SAT) • Estimated oxygen content (O2CT) • Alveolar-arterial oxygen pressure gradient (pO2(A–a)) and alveolar-arterial oxygen pressure ratio (pO2(a/A)) • Anion gap (AnGap) • Estimated total hemoglobin content (ctHb(est)) • Adjusted calcium ion concentration (Ca++(7,4)) • Oxygen tension in arterial blood to inspired oxygen concentration ratio (pO2/FIO2) The system is also designed to determine pH, pCO2, Na+, K+, and Ca++ in the original acetate and bicarbonate buffer solutions. When used in buffer solution mode, the results are displayed on the touch screen according to pH or H+, mmHg or kPa for pCO2, and mmol/L for Na+, K+, and Ca++. In buffer solution mode, the system will calculate the actual bicarbonate concentration (HCO3–act) and total carbon dioxide content (ctCO2).
Dates and Status
Aug 27, 2024
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