Personal Blood Glucose Meter - Vietnam Registration 2300901ĐKLH/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 2300901ĐKLH/BYT-HTTB and manufactured by Sanmina Corporation.

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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2300901ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2300901ĐKLH/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

2300901ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-211029-0015

Product Type

ACCU-CHEK® Guide Link (mg/dL Kit)

Product Code

08116083203

Technical Details

Intended Use

The Accu-Chek Guide Link and Accu-Chek Guide blood glucose meter are used to quantitate the concentration of glucose in the whole blood obtained from the fingertips, palm, forearm, and upper arm, and are a tool for effective monitoring of blood glucose control. The Accu-Chek Guide Link and Accu-Chek Guide blood glucose meter are used by people with diabetes to perform in vitro diagnostic self-testing. The Accu-Chek Guide Link and Accu-Chek Guide blood glucose meter are used by healthcare professionals to perform in vitro diagnostic point-of-care testing for patients in healthcare facilities. Only healthcare professionals are permitted to perform venous, arterial, and umbilical cord blood testing. The Accu-Chek Guide Link blood glucose meter system is designed to wirelessly transmit blood glucose values to compatible MiniMed™ insulin pumps equipped with Bluetooth® technology, via a low-energy Bluetooth connection. It is intended for self-measurement.