Taiwan FDA registration 10cfc2c41bc125fb9c4050b21a733265

Keyouga blood glucose monitoring system

TW: 克優加血糖監測系統

Taiwan·Risk Class 2·SunYao Technology Co., Ltd. Shulin Plant;; Ruiying Biopharmaceutical Technology Co., Ltd·Registered Dec 09, 2020 – Dec 09, 2025Expired

Registration details

Analysis ID: 10cfc2c41bc125fb9c4050b21a733265

Company information

Manufacturer: SunYao Technology Co., Ltd. Shulin Plant;; Ruiying Biopharmaceutical Technology Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: AURUM BIOMEDICAL TECHNOLOGY, INC.

Product details

Intended Use: This product is used to quantitatively detect the blood glucose value of fresh microvascular whole blood, which can be used by patients for self-testing, and should not be used as a diabetes diagnostic tool, and this product is not suitable for neonatal detection.
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: QMS/QSD;; 國產

Dates and status

Registration Date: Dec 09, 2020
Expiry Date: Dec 09, 2025

About this record

Access comprehensive regulatory information for Keyouga 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 10cfc2c41bc125fb9c4050b21a733265 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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