Vietnam MOH registration 2403212ĐKLH/BYT-HTTB

Hemoglobin A1c Measurement System

VN: Hệ thống đo đường huyết

Vietnam·Risk Class TTBYT Loại C·ACCU-CHEK® Guide Link (mmol/L Kit)·Sanmina Corporation·Registered Nov 02, 2024

Registration details

Analysis ID: 2403212ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-211029-0016
Product Type: ACCU-CHEK® Guide Link (mmol/L Kit)
Product Code: 08116113186

Company information

Manufacturer: Sanmina Corporation
Manufacturer Country: UNITED STATES
Product Owner: Roche Diabetes Care GmbH
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

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.

Dates and status

Registration Date: Nov 02, 2024

About this record

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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