Taiwan FDA registration 827b060828cb7a786546c2f5bc78f3ed

Vitron Test System (Blood Glucose, Ketone Body, Total Cholesterol)

TW: 威創測試系統(血糖、酮體、總膽固醇)

Taiwan·Risk Class 2·Taibo Technology Co., Ltd. five-stock factory·Registered Mar 17, 2023 – Nov 27, 2028Active

Registration details

Analysis ID: 827b060828cb7a786546c2f5bc78f3ed

Company information

Manufacturer: Taibo Technology Co., Ltd. five-stock factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: TAIDOC TECHNOLOGY CORPORATION

Product details

Intended Use: 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.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1435 Ketone (non-quantitative) testing system;; A.1345 Glucose Test System;; A.1175 Cholesterol (Total) Testing System
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Mar 17, 2023
Expiry Date: Nov 27, 2028

About this record

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.

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