Taiwan FDA registration 34a590e92fe3f183873d96cd8cc3dae4

Tyson Bio HS100/HS100-B/HS200/HS200-B Blood Glucose Monitoring System。

TW: 良測參號血糖測試套組

Taiwan·Risk Class 2·MD·TYSON BIORESEARCH INC.·Registered Feb 20, 2019 – Feb 20, 2029Active

Registration details

Analysis ID: 34a590e92fe3f183873d96cd8cc3dae4
License Form: Ministry of Health Medical Device Manufacturing No. 006282

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 diagnostics, quantitatively measuring fresh microvascular whole blood and venous whole blood from fingertips, palms or forearms, and is not suitable for neonatal diagnosis. It can be used by the general public (single person) and professionals to monitor diabetes.
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: Feb 20, 2019
Expiry Date: Feb 20, 2029

About this record

Access comprehensive regulatory information for Tyson Bio HS100/HS100-B/HS200/HS200-B 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 34a590e92fe3f183873d96cd8cc3dae4 and manufactured by TYSON BIORESEARCH INC.. The authorized representative in Taiwan is TYSON BIORESEARCH INC..

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