Taiwan FDA registration 663b42963b0012700f3a264e33a568fa

Ruiying optimal blood glucose monitoring system

TW: 瑞瑩優測血糖監測系統
Taiwan flagTaiwan·Risk Class 2·SunYao Technology Co., Ltd. Shulin Plant;; Ruiying Biopharmaceutical Technology Co., Ltd·Registered Dec 18, 2020 – Dec 18, 2025Expired
Registration details
Analysis ID
663b42963b0012700f3a264e33a568fa
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
AURUM BIOMEDICAL TECHNOLOGY, INC.
Product details
Intended Use
This product is used to quantify the blood glucose value of fresh microvascular whole blood and can be used by patients for self-testing. It is for in vitro diagnostic use only and should not be used as a diabetes diagnostic tool, and this product is not suitable for newborn testing. This product is intended for single use only.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1660 Quality control materials (analytical and non-analytical); A.1345 Glucose test system
Import Information
國產;; QMS/QSD
Dates and status
Registration Date
Dec 18, 2020
Expiry Date
Dec 18, 2025
About this record

Access comprehensive regulatory information for Ruiying optimal 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 663b42963b0012700f3a264e33a568fa and manufactured by SunYao Technology Co., Ltd. Shulin Plant;; Ruiying Biopharmaceutical Technology Co., Ltd. The authorized representative in Taiwan is AURUM BIOMEDICAL TECHNOLOGY, INC..

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