Personal Blood Glucose Meter - Vietnam Registration 2403578ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Personal Blood Glucose Meter in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403578ĐKLH/BYT-HTTB and manufactured by Flextronics Industrial (Shenzhen) Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH DKSH VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Acon Biotech (Hangzhou) Co., Ltd., SD Biosensor, INC., 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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2403578ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2403578ĐKLH/BYT-HTTB

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Device Details

Personal Blood Glucose Meter

VN: Máy đo đường huyết cá nhân

Risk Class TTBYT Loại C

Registration Details

Analysis ID

2403578ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-231010-0003

Product Type

OneTouch Select Plus Simple mg/dL

Product Code

02412002

Technical Details

Intended Use

It is used to measure the amount of glucose (sugar) in the blood samples taken from the fingertips. This system is intended for individual patients and should not be shared. It is intended for external self-testing (in vitro diagnostic purpose) for people with diabetes who use it at home and for healthcare professionals in the clinic as a supportive tool to monitor the effectiveness of diabetes control. It is not intended for the diagnosis or screening of diabetes or for use in newborns. It is not intended for patients with severe illness, shock, dehydration, or hyperosmotic stress.