Taiwan FDA registration 3347c6f9648cec8b5e270a634007e07b

Ruiying Bang blood glucose monitoring system

TW: 瑞瑩邦測血糖監測系統

Taiwan·Risk Class 2·Ruiying Biomedical Technology Co., Ltd.;; Ruizhi Biochemical Technology Co., Ltd·Registered Mar 17, 2021 – Dec 18, 2025Expired

Registration details

Analysis ID: 3347c6f9648cec8b5e270a634007e07b

Company information

Manufacturer: Ruiying Biomedical Technology Co., Ltd.;; Ruizhi Biochemical 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 and can be used by patients for self-testing. It is for in vitro diagnostic use only and should not be used as a diagnostic tool for diabetes, and this system is not suitable for newborn detection. This product is intended for single use only.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1345 Glucose Test System
Import Information: QMS/QSD;; 國產

Dates and status

Registration Date: Mar 17, 2021
Expiry Date: Dec 18, 2025

About this record

Access comprehensive regulatory information for Ruiying Bang 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 3347c6f9648cec8b5e270a634007e07b and manufactured by Ruiying Biomedical Technology Co., Ltd.;; Ruizhi Biochemical Technology Co., Ltd. The authorized representative in Taiwan is AURUM BIOMEDICAL TECHNOLOGY, INC..

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