Taiwan FDA registration bd358e58e3731e7bcb7fcc302bd32ba9

WowGoHealth Blood Glucose Monitoring System

TW: 高登血糖測試系統

Taiwan·Risk Class 2·MD·Hengxin Medical Equipment Co., Ltd·Registered Feb 08, 2018 – Feb 08, 2023Expired

Registration details

Analysis ID: bd358e58e3731e7bcb7fcc302bd32ba9
License Form: Ministry of Health Medical Device Manufacturing No. 005817

Company information

Manufacturer: Hengxin Medical Equipment Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: GOLDEN SMART HOME TECHNOLOGY CORP.

Product details

Intended Use: It is used to quantitatively detect the blood glucose of microvascular whole blood in the fingertips and palms, not suitable for newborns, can be self-tested during home health care, and is suitable for medical institutions to monitor the blood glucose value 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): A1345 Glucose Test System
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Feb 08, 2018
Expiry Date: Feb 08, 2023

About this record

Access comprehensive regulatory information for WowGoHealth 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 bd358e58e3731e7bcb7fcc302bd32ba9 and manufactured by Hengxin Medical Equipment Co., Ltd. The authorized representative in Taiwan is GOLDEN SMART HOME TECHNOLOGY CORP..

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