Personal Blood Glucose Meter
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Theo theo phụ lục·Registered Sep 26, 2023- Analysis ID
- 2300896ĐKLH/BYT-HTTB
- Submission ID
- 17002769/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Theo theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Intended Use
- The Accu-Chek Instant S blood glucose meter and the Accu-Chek Instant test strip are used to measure the concentration of glucose in the whole blood obtained from the tip of the finger, palm, forearm, and upper arm, and they are a tool for effectively monitoring blood glucose control. The Accu-Chek Instant S blood glucose meter and the Accu-Chek Instant test strip are used by people with diabetes to perform in vitro diagnostic self-testing. The Accu-Chek Instant S blood glucose meter and the Accu-Chek Instant test strip are used by medical personnel to perform in vitro diagnostic testing for patients at medical facilities. Only medical personnel are authorized to perform venous, arterial, and umbilical cord blood testing. This system is not intended for the diagnosis of diabetes and should not be used to test fetal cord blood samples.
- 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 2300896ĐKLH/BYT-HTTB and manufactured by Theo theo phụ lục.
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