Automated Hematology Analyzer - Vietnam Registration 240000543/PCBB-HN

Access comprehensive regulatory information for Automated Hematology Analyzer 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 240000543/PCBB-HN and manufactured by Tecom Science Corporation. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI DỊCH VỤ TRÍ VIỆT PHÁT.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Theo theo phụ lục, Horiba ABX SAS, and 5 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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240000543/PCBB-HN

Registration Details

Vietnam MOH Registration: 240000543/PCBB-HN

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Device Details

Automated Hematology Analyzer

VN: Máy xét nghiệm huyết học tự động

Risk Class TTBYT Loại B

Registration Details

Analysis ID

240000543/PCBB-HN

Submission ID

000.00.19.H26-240116-0011

Product Type

TEK8520

Technical Details

Intended Use

The blood test uses a dual-channel system combining impedance, laser scattering, and cell morphology to simultaneously detect white blood cells; it uses a cyanide-free colorimetric method to measure hemoglobin concentration; it uses optical methods to count WBC and BASO; and it uses a multi-angle laser flow cytology technique to obtain a statistical count of five types of white blood cells.