Automated Hematology Analyzer, Accessories, Testing Chemicals, Control Materials, and Calibration Standards - Vietnam Registration 240001287/PCBB-HN
Access comprehensive regulatory information for Automated Hematology Analyzer, Accessories, Testing Chemicals, Control Materials, and Calibration Standards 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 240001287/PCBB-HN and manufactured by TECOM SCIENCE CORPORATION. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ KỸ THUẬT CÔNG NGHỆ NHẬT MINH.
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Device Details
Registration Details
240001287/PCBB-HN
000.00.19.H26-240507-0044
Theo theo phụ lục
Theo phụ lục
Technical Details
The Tecom Automated Hematology Analyzer, including its accessories, reagents, and the control material and calibrator, is a system for automated hematology analysis, used for in vitro diagnosis in clinical laboratories. It is designed to analyze only human blood samples, human body fluids, or blood samples, serum, plasma, urine, and cerebrospinal fluid. Other uses are considered non-compliant.
Dates and Status
May 31, 2024