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Vitron Test System (Blood Glucose, Ketone Body, Total Cholesterol) - Taiwan Registration 827b060828cb7a786546c2f5bc78f3ed

Access comprehensive regulatory information for Vitron Test System (Blood Glucose, Ketone Body, Total Cholesterol) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 827b060828cb7a786546c2f5bc78f3ed and manufactured by Taibo Technology Co., Ltd. five-stock factory. The authorized representative in Taiwan is TAIDOC TECHNOLOGY CORPORATION.

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.

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827b060828cb7a786546c2f5bc78f3ed
Registration Details
Taiwan FDA Registration: 827b060828cb7a786546c2f5bc78f3ed
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Device Details

Vitron Test System (Blood Glucose, Ketone Body, Total Cholesterol)
TW: ๅจๅ‰ตๆธฌ่ฉฆ็ณป็ตฑ(่ก€็ณ–ใ€้…ฎ้ซ”ใ€็ธฝ่†ฝๅ›บ้†‡)
Risk Class 2

Registration Details

827b060828cb7a786546c2f5bc78f3ed

Company Information

Taiwan, Province of China

Product Details

This product is an in vitro diagnostic medical device that provides professionals with quantitative detection of glucose, ketone and cholesterol concentrations in the blood. Glucose and ketone measurements must be done using fresh microvascular whole blood or venous whole blood. Cholesterol measurement is measured using fresh microvascular whole blood. Not suitable for diagnosis and screening of diseases.

A Clinical chemistry and clinical toxicology

A.1435 Ketone (non-quantitative) testing system;; A.1345 Glucose Test System;; A.1175 Cholesterol (Total) Testing System

ๅœ‹็”ข;; QMS/QSD

Dates and Status

Mar 17, 2023

Nov 27, 2028