Automated Hematology Analyzer, Accessories, Testing Chemicals, Control Materials, and Calibration Standards
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·TECOM SCIENCE CORPORATION·Registered May 31, 2024- Analysis ID
- 240001287/PCBB-HN
- Submission ID
- 000.00.19.H26-240507-0044
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- TECOM SCIENCE CORPORATION
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- TECOM SCIENCE CORPORATION
- Authorized Representative
- CÔNG TY TNHH THIẾT BỊ KỸ THUẬT CÔNG NGHỆ NHẬT MINH
- Intended Use
- 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.
- Registration Date
- May 31, 2024
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.
This page provides complete technical specifications, regulatory compliance details. 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.