Taiwan FDA registration 393919a683e3c0d095a6e6544082e910

Gordon blood glucose testing system

TW: 高登血糖測試系統

Taiwan·Risk Class 2·Golden Intelligent Technology Co., Ltd.;; Xunying Optoelectronics Co., Ltd·Registered Aug 10, 2020 – Aug 10, 2025Expired

Registration details

Analysis ID: 393919a683e3c0d095a6e6544082e910

Company information

Manufacturer: Golden Intelligent Technology Co., Ltd.;; Xunying Optoelectronics Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: GOLDEN SMART HOME TECHNOLOGY CORP.

Product details

Intended Use: This product is used to quantitatively detect the blood glucose of microvascular whole blood in fingertips and forearms, and is not suitable for newborns. This blood glucose testing system is suitable for self-testing blood glucose values during home health care and is suitable for medical institutions to monitor blood glucose levels of diabetic patients. This product is not intended for the diagnosis or determination of diabetes.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1345 Glucose Test System
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Aug 10, 2020
Expiry Date: Aug 10, 2025

About this record

Access comprehensive regulatory information for Gordon blood glucose testing system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 393919a683e3c0d095a6e6544082e910 and manufactured by Golden Intelligent Technology Co., Ltd.;; Xunying Optoelectronics Co., Ltd. The authorized representative in Taiwan is GOLDEN SMART HOME TECHNOLOGY CORP..

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