Urine Analysis Machine - Vietnam Registration 220001609/PCBB-BYT

Access comprehensive regulatory information for Urine 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 220001609/PCBB-BYT and manufactured by 77 Elektronika Muszeripari Kft..

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Theo theo phụ lục, YD Diagnostics CORP, and 5 recent registrations in the same category. 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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220001609/PCBB-BYT

Registration Details

Vietnam MOH Registration: 220001609/PCBB-BYT

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Device Details

Urine Analysis Machine

VN: Máy phân tích nước tiểu

Risk Class TTBYT Loại B

Registration Details

Analysis ID

220001609/PCBB-BYT

Submission ID

000.00.04.G18-220313-0001

Product Type

Urilyzer 500 Pro

Product Code

UL0500Pro

Technical Details

Intended Use

The Urilyzer 500 Pro is a desktop device designed for in vitro diagnosis using CombiScreen 11SYS Plus and CombiScreen 11SYS test strips produced by Analyticon Biotechnologies GmbH. The system performs semiquantitative detection of the following analytes in urine: Bilirubin, Urobilinogen, Ketones, Ascorbic Acid, Glucose, Protein (Albumin), Blood (Hemoglobin), pH, Nitrite, Leukocytes, and Specific Gravity. The Urilyzer 500 Pro is used in professional settings and centralized laboratory locations. The analyzer is designed to be used in screening at-risk patients to support diagnosis in the following areas: – Renal Function – Urinary Tract Infection – Metabolic Disorders – Carbohydrate Metabolism – Liver Function