Vietnam MOH registration 240002287/PCBB-HN

System for Measuring Ketone Concentration in Blood

VN: Hệ thống đo nồng độ Keton trong máu

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·VISGENEER, Inc. (Hsinchu Factory)·Registered Sep 04, 2024

Registration details

Analysis ID: 240002287/PCBB-HN
Submission ID: 000.00.19.H26-240831-0004
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: VISGENEER, Inc. (Hsinchu Factory)
Manufacturer Country: Theo theo phụ lục
Product Owner: VISGENEER, Inc. (Hsinchu Factory)
Authorized Representative: CÔNG TY TNHH THIẾT BỊ CÔNG NGHỆ NGUYỄN GIA

Technical details

Intended Use: 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

Registration Date: Sep 04, 2024

About this record

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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