Taiwan FDA registration c5658fee0dc153a5072161e3b161f882

Tyson Bio AC500 Blood Glucose Monitoring System

TW: 良測貳號血糖測試套組

Taiwan·Risk Class 2·MD·TYSON BIORESEARCH INC.·Registered Mar 26, 2019 – Mar 26, 2029Active

Registration details

Analysis ID: c5658fee0dc153a5072161e3b161f882
License Form: Ministry of Health Medical Device Manufacturing No. 006287

Company information

Manufacturer: TYSON BIORESEARCH INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: TYSON BIORESEARCH INC.

Product details

Intended Use: This product is intended for in vitro diagnostic use to measure microvascular whole blood glucose values on fingertips, palms or forearms, and is not suitable for neonatal diagnosis. Only applicable to personal blood glucose monitoring.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A1345 Glucose Test System
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Mar 26, 2019
Expiry Date: Mar 26, 2029

About this record

Access comprehensive regulatory information for Tyson Bio AC500 Blood Glucose 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 c5658fee0dc153a5072161e3b161f882 and manufactured by TYSON BIORESEARCH INC.. The authorized representative in Taiwan is TYSON BIORESEARCH INC..

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