Vietnam MOH registration 240000585/PCBB-HN

Urinary Tract Endoscopy Machine

VN: Máy soi cặn nước tiểu

Vietnam·Risk Class TTBYT Loại B·Urilyzer® Cell/ Urine Microscopy Analyzer·77 Elektronika Muszeripari Kft.·Registered Mar 18, 2024

Registration details

Analysis ID: 240000585/PCBB-HN
Submission ID: 000.00.19.H26-240228-0028
Product Type: Urilyzer® Cell/ Urine Microscopy Analyzer
Product Code: ULC060

Company information

Manufacturer: 77 Elektronika Muszeripari Kft.
Product Owner: 77 Elektronika Muszeripari Kft.
Authorized Representative: CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG

Technical details

Intended Use: Repetitive quantitative and semi-quantitative analysis of 15 sediment-forming particles in natural urine samples, including: red blood cells, white blood cells and clumps of white blood cells, hyaline casts, scale-like epithelial cells, non-scale-like epithelial cells, pathological casts, bacteria, fungi, crystals, monohydrate calcium oxalate, dihydrate calcium oxalate, uric acid, triple phosphate, mucus, and sperm.

Dates and status

Registration Date: Mar 18, 2024

About this record

Access comprehensive regulatory information for Urinary Tract Endoscopy 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 240000585/PCBB-HN and manufactured by 77 Elektronika Muszeripari Kft.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG.

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