Vietnam MOH registration 240002911/PCBB-HN

Continuous Glucose Monitoring System

VN: Bộ theo dõi glucose liên tục

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Zhejiang POCTech Co., Ltd.·Registered Oct 28, 2024

Registration details

Analysis ID: 240002911/PCBB-HN
Submission ID: 000.00.19.H26-241024-0028
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Zhejiang POCTech Co., Ltd.
Manufacturer Country: Theo theo phụ lục
Product Owner: Zhejiang POCTech Co., Ltd.
Authorized Representative: CÔNG TY CỔ PHẦN VIỄN THÔNG FPT

Technical details

Intended Use: 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

Registration Date: Oct 28, 2024

About this record

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.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.