Taiwan FDA registration 9f2f441cc153820d0f618a5ca34b820e

Ruida blood glucose monitoring system

TW: 瑞達血糖監測系統

Taiwan·Risk Class 2·SunYao Technology Co., Ltd. Shulin Plant;; Ruiying Biopharmaceutical Technology Co., Ltd·Registered Aug 25, 2021 – Dec 09, 2025Expired

Registration details

Analysis ID: 9f2f441cc153820d0f618a5ca34b820e

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 quantify 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 system is not suitable for newborn 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: Aug 25, 2021
Expiry Date: Dec 09, 2025

About this record

Access comprehensive regulatory information for Ruida 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 9f2f441cc153820d0f618a5ca34b820e 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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