Vietnam MOH registration 240000441/PCBB-HN

They are evaluating the quantitative biochemical urine test

VN: Họ que thử xét nghiệm bán định lượng sinh hóa nước tiểu

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·URIT Medical Electronic Co., Ltd.·Registered Mar 07, 2024

Registration details

Analysis ID: 240000441/PCBB-HN
Submission ID: 000.00.19.H26-240206-0004
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: URIT Medical Electronic Co., Ltd.
Manufacturer Country: Theo theo phụ lục
Product Owner: URIT Medical Electronic Co., Ltd.
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ Y TẾ LABOMED

Technical details

Intended Use: The Urit 11FA/12FA/14FA test strip provides qualitative tests for ascorbic acid, nitrite, microalbumin, leukocytes, creatinine, ketones, urobilinogen, bilirubin, glucose, protein, specific gravity, pH, blood, and calcium in urine. Please refer to the package insert or the vial label to determine which tests are included in the product you are using. It is intended to be used with the Urit-1550, Urit-1560, Urit-1600, Urit-1610, Urit-1600PLUS, UC-1800, UC-1810, Urit-560, UC-58, UC-580, and AI-Libre US -1680, US-1681 urinalysis machines.

Dates and status

Registration Date: Mar 07, 2024

About this record

Access comprehensive regulatory information for They are evaluating the quantitative biochemical urine test 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 240000441/PCBB-HN and manufactured by URIT Medical Electronic Co., Ltd.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ Y TẾ LABOMED.

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