Taiwan FDA registration 21887959c19f1a3b22c8d37825ca0c95

FlexTest transmission type blood pressure/blood glucose/cholesterol monitoring system

TW: 易立測傳輸型血壓/血糖/膽固醇監測系統

Taiwan·Risk Class 2·BIOPTIK TECHNOLOGY, INC.·Registered May 16, 2017 – May 16, 2027Active

Registration details

Analysis ID: 21887959c19f1a3b22c8d37825ca0c95

Company information

Manufacturer: BIOPTIK TECHNOLOGY, INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: BIOPTIK TECHNOLOGY, INC.

Product details

Intended Use: This product provides blood pressure measurement function, including arterial diastolic blood pressure and systolic blood pressure, and can also quantitatively detect blood glucose and cholesterol content in fingertip microvascular whole blood. Blood pressure measurement is suitable for adults over 16 years old, blood glucose and cholesterol measurement is not suitable for newborn testing.
Product Type (Level 1): A more 1.50.55.00.a.s. It's not a one-way trip.
Product Type (Level 2): E.1130 Non-invasive blood pressure measurement systems;; A.1345 Glucose Test System;; A.1175 Cholesterol (Total) Testing System
Import Information: Domestic

Dates and status

Registration Date: May 16, 2017
Expiry Date: May 16, 2027

About this record

Access comprehensive regulatory information for FlexTest transmission type blood pressure/blood glucose/cholesterol monitoring system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 21887959c19f1a3b22c8d37825ca0c95 and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is BIOPTIK TECHNOLOGY, INC..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.