Personal Blood Glucose Meter
- Analysis ID
- 2403578ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-231010-0003
- Product Type
- OneTouch Select Plus Simple mg/dL
- Product Code
- 02412002
- Manufacturer
- Flextronics Industrial (Shenzhen) Co., Ltd.
- Manufacturer Country
- CHINA
- Authorized Representative
- CÔNG TY TNHH DKSH VIỆT NAM
- Intended Use
- It is used to measure the amount of glucose (sugar) in the blood samples taken from the fingertips. This system is intended for individual patients and should not be shared. It is intended for external self-testing (in vitro diagnostic purpose) for people with diabetes who use it at home and for healthcare professionals in the clinic as a supportive tool to monitor the effectiveness of diabetes control. It is not intended for the diagnosis or screening of diabetes or for use in newborns. It is not intended for patients with severe illness, shock, dehydration, or hyperosmotic stress.
- Registration Date
- Nov 14, 2024
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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 2403578ĐKLH/BYT-HTTB and manufactured by Flextronics Industrial (Shenzhen) Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH DKSH VIỆT NAM.
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