Personal Blood Glucose Meter
Vietnam·Risk Class TTBYT Loại C·ACCU-CHEK® Guide Link (mg/dL Kit)·Sanmina Corporation·Registered Sep 26, 2023- 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
- Manufacturer
- Sanmina Corporation
- Manufacturer Country
- UNITED STATES
- 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.
- Registration Date
- Sep 26, 2023
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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.
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