Vietnam MOH registration 240000774/PCBB-HCM

Automated Urinalysis Machine

VN: Máy xét nghiệm nước tiểu bán tự động
Vietnam flagVietnam·Risk Class TTBYT Loại B·Urilyzer Cell Urine Microscopy Analyzer·77 Electronika Model and Specification Kft.·Registered Apr 11, 2024
Registration details
Analysis ID
240000774/PCBB-HCM
Submission ID
000.00.19.H29-240126-0026
Product Type
Urilyzer Cell Urine Microscopy Analyzer
Product Code
ULC060
Company information
Product Owner
77 Elektronika Müszeripari Kft.
Authorized Representative
CÔNG TY TNHH SIEMENS HEALTHCARE
Technical details
Intended Use
This device is a semi-automatic analyzer. The analyzer is designed to be used for professional diagnosis in in vitro experiments in clinical laboratories. The analyzer is a screening device for urine samples from humans. The measurement results are very useful in evaluating kidney, urinary tract, and metabolic disorders by analyzing the following parameters in the urine sample: Red blood cells (RBC); White blood cells (WBC) quantitatively; Granular white blood cells (WBCc); Hyaline casts (HYA); Pathological casts (Pat); Epithelial cells (EPI); Non-keratinized epithelial cells (NEC); Bacteria (BAC): Rod-shaped bacteria (BACr), Cocci bacteria (BACc); Yeast (YEA); Crystals (CRY): Monohydrate calcium oxalate (CaOxm), Dihydrate calcium oxalate (CaOxd), Uric acid (URI), Triple phosphate (Tri); Mucus; Sperm (SPRM); quantitatively.
Dates and status
Registration Date
Apr 11, 2024
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About this record

Access comprehensive regulatory information for Automated Urinalysis 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 240000774/PCBB-HCM and manufactured by 77 Electronika Model and Specification Kft.. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.

This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including Beckman Coulter, Inc., Beckman Coulter, Inc.,, and 3 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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