Hemoglobin A1c Measurement System - Vietnam Registration 2403212ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Hemoglobin A1c Measurement System 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 2403212ĐKLH/BYT-HTTB and manufactured by Sanmina Corporation. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2403212ĐKLH/BYT-HTTB
000.00.04.G18-211029-0016
ACCU-CHEK® Guide Link (mmol/L Kit)
08116113186
Technical Details
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.
Dates and Status
Nov 02, 2024