Urinary Sediment Analysis Machine - Vietnam Registration 240001122/PCBB-HCM
Access comprehensive regulatory information for Urinary Sediment Analysis Machine in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001122/PCBB-HCM and manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH Y TẾ MINDRAY VIỆT NAM.
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Device Details
Registration Details
240001122/PCBB-HCM
000.00.19.H29-240527-0018
Theo theo phụ lục
Theo phụ lục
Technical Details
The urine sediment analyzer is an in vitro diagnostic device used to quantitatively analyze the urine sample of a human in the laboratory environment. Clinically, the analyzer determines and analyzes the components of the sediment in the urine sample of a human, including red blood cells (RBC), white blood cells (WBC), total white blood cells (WBCC), bacteria (BACT), gram-negative bacteria (BACTc), gram-positive bacteria (BACTr), yeast (YST), squamous epithelial cells (SEC), non-squamous epithelial cells (NEC), crystals (CRYS), monohydrated calcium oxalate (Caoxm), dihydrated calcium oxalate (Caoxd), uric acid (URI), triphosphate (TRI), hyaluronic acid (HYAC), unclassified rod (UNCC), mucus (MUC) and sperm (SPRM).
Dates and Status
Jun 03, 2024