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pH Quantitative Test Card, pCO2, pO2, cNa+, cK+, cCa2+, cCl-, Hct, cLac - Vietnam Registration 2402218ĐKLH/BYT-HTTB

Access comprehensive regulatory information for pH Quantitative Test Card, pCO2, pO2, cNa+, cK+, cCa2+, cCl-, Hct, cLac 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 2402218ĐKLH/BYT-HTTB and manufactured by Radiometer Medical ApS. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.

This page provides complete technical specifications, regulatory compliance details. 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.

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2402218ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2402218ĐKLH/BYT-HTTB
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Device Details

pH Quantitative Test Card, pCO2, pO2, cNa+, cK+, cCa2+, cCl-, Hct, cLac
VN: Thẻ xét nghiệm định lượng pH, pCO2, pO2, cNa+, cK+, cCa2+, cCl-, Hct, cLac
Risk Class TTBYT Loại C

Registration Details

2402218ĐKLH/BYT-HTTB

000.00.04.G18-211123-0024

ABL80 SC80

945-813

Company Information

Theo theo phụ lục

Radiometer Medical ApS

Technical Details

The ABL80 SC80 test card is an in vitro diagnostic medical device used with the ABL80 and SP80 Solution Pack electrolyte analyzers. ABL80 FLEX is a portable, automated blood gas and electrolyte analyzer that measures pH, blood gas, electrolytes, glucose, lactate, hematocrit (ABL80 FLEX) and oxygen saturation (ABL80 FLEX CO-OX) in whole blood samples. The ABL80 FLEX electrolyte and blood gas analyzer is used by trained technicians, nurses, doctors, and clinicians in clinical laboratories or at the point of care. The ABL80 FLEX and ABL80 FLEX CO-OX are in vitro diagnostic medical devices and are used for quantitative testing to support clinical decision-making in the diagnosis of a variety of disorders related to metabolism, respiration, endocrinology, hematology, cardiology, and infection in the general patient population.

Dates and Status

Aug 27, 2024