Continuous Glucose Monitoring System - Vietnam Registration 240002911/PCBB-HN
Access comprehensive regulatory information for Continuous Glucose Monitoring System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002911/PCBB-HN and manufactured by Zhejiang POCTech Co., Ltd.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN VIỄN THÔNG FPT.
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Device Details
Registration Details
240002911/PCBB-HN
000.00.19.H26-241024-0028
Theo theo phụ lục
Theo phụ lục
Technical Details
The Continuous Glucose Monitoring 3P (CGM 3P, including the sensor and the data transmitter) is a continuous real-time glucose monitoring device intended for the management of type 2 diabetes in adults (age ≥ 14). The interpretation of the device's results must be based on the glucose trend and a few time-based sequential indices. The device also supports the detection of hypoglycemic and hyperglycemic episodes. This device is intended for use in a single patient.
Dates and Status
Oct 28, 2024