Vietnam MOH registration 240001122/PCBB-HCM

Urinary Sediment Analysis Machine

VN: Máy xét nghiệm cặn lắng nước tiểu

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·Registered Jun 03, 2024

Registration details

Analysis ID: 240001122/PCBB-HCM
Submission ID: 000.00.19.H29-240527-0018
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer Country: Theo theo phụ lục
Product Owner: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Authorized Representative: CÔNG TY TNHH Y TẾ MINDRAY VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Jun 03, 2024

About this record

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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