Automated Urinalysis Machine
- Analysis ID
- 240000774/PCBB-HCM
- Submission ID
- 000.00.19.H29-240126-0026
- Product Type
- Urilyzer Cell Urine Microscopy Analyzer
- Product Code
- ULC060
- Manufacturer
- 77 Electronika Model and Specification Kft.
- Product Owner
- 77 Elektronika Müszeripari Kft.
- Authorized Representative
- CÔNG TY TNHH SIEMENS HEALTHCARE
- 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.
- Registration Date
- Apr 11, 2024
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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.