Vietnam MOH registration 240001482/PCBB-HN

IVD Kit for Urine Sediment Testing

VN: Bộ IVD xét nghiệm cặn nước tiểu

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Dirui Industrial Co., Ltd·Registered Jun 24, 2024

Registration details

Analysis ID: 240001482/PCBB-HN
Submission ID: 000.00.19.H26-240614-0024
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Dirui Industrial Co., Ltd
Manufacturer Country: Theo theo phụ lục
Product Owner: Dirui Industrial Co., Ltd
Authorized Representative: CÔNG TY TNHH THƯƠNG MẠI DỊCH VỤ TRÍ ĐỨC

Technical details

Intended Use: Urine Sediment Analyzer Reagent Sheath: Used to coat the sample and form the diluted flow to count the physical components of urine Urine Sediment Analyzer Reagent Diluent: Used to dilute the sample Focus: Focus is used to determine the position of the focal plane of the microscope imaging system Positive Control: Used for quality control (QC) in the testing process Negative Control: Used for quality control (QC) in the testing process Standard Solution: Used to calibrate the urine sediment analyzer machine to ensure the accuracy of the test results.

Dates and status

Registration Date: Jun 24, 2024

About this record

Access comprehensive regulatory information for IVD Kit for Urine Sediment Testing 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 240001482/PCBB-HN and manufactured by Dirui Industrial Co., Ltd. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI DỊCH VỤ TRÍ ĐỨC.

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.