System for Measuring Ketone Concentration in Blood - Vietnam Registration 240002287/PCBB-HN
Access comprehensive regulatory information for System for Measuring Ketone Concentration in Blood 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 240002287/PCBB-HN and manufactured by VISGENEER, Inc. (Hsinchu Factory). The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ CÔNG NGHỆ NGUYỄN GIA.
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Device Details
Registration Details
240002287/PCBB-HN
000.00.19.H26-240831-0004
Theo theo phụ lục
Theo phụ lục
Technical Details
Used to measure the concentration of β-Ketone (beta-hydroxybutyrate) in the whole blood of fresh capillary blood taken from the finger. The test is performed outside the body (using in vitro diagnosis). The system is intended for self-use at home or by medical professionals to manage patients concerned about their ketone levels.
Dates and Status
Sep 04, 2024