Pure Global

Drug Testing, Control Material, Diagnostic Reference Standard for In Vitro Use in Chromatographic Analysis Machines - Vietnam Registration 240000020/PCBB-HP

Access comprehensive regulatory information for Drug Testing, Control Material, Diagnostic Reference Standard for In Vitro Use in Chromatographic Analysis Machines in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240000020/PCBB-HP and manufactured by Shanghai Kehua Bio-Engineering Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH CÔNG NGHỆ TIANLONG VIỆT NAM.

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.

Free Database
Powered by Pure Global AI
300,000+ Devices
240000020/PCBB-HP
Registration Details
Vietnam MOH Registration: 240000020/PCBB-HP
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Device Details

Drug Testing, Control Material, Diagnostic Reference Standard for In Vitro Use in Chromatographic Analysis Machines
VN: Thuốc thử, vật liệu kiểm soát, chất hiệu chuẩn chẩn đoán Invitro sử dụng cho máy phân tích hóa sinh
Risk Class TBYT Loại B

Registration Details

240000020/PCBB-HP

000.00.18.H24-240819-0002

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Shanghai Kehua Bio-Engineering Co., Ltd.

Technical Details

System Calibrator Level 2 is designed to be used as a calibrator for multiple clinical chemistry tests KHB. Control Serum Level 1 is used as a quality control measure for multiple clinical chemistry tests KHB. Control Serum Level 2 is used as a quality control measure for multiple clinical chemistry tests KHB. Enzyme Multical Calibrator is intended to be used as a calibrator for multiple clinical chemistry tests KHB. Enzyme Multical Control is intended to be used as a quality control measure for multiple clinical chemistry tests KHB. Immunology Multi Control is intended to be used as a quality control measure for multiple clinical chemistry tests KHB. Lipid Quality Control is intended to be used as a quality control measure for multiple clinical chemistry tests KHB. Rheumatism Multi Control is intended to be used as a quality control measure for multiple clinical chemistry tests KHB. Urinary Control is intended to be used as a quality control measure for multiple clinical chemistry tests KHB.

Dates and Status

Sep 12, 2024