Taiwan FDA registration e1aee39bca8f1d1df7a3be20cb34d259

Wenhao Smart Superior Blood Glucose Monitoring System

TW: 穩豪智優型血糖監測系統
Taiwan flagTaiwan·Risk Class 2·Flextronics Industrial (Shenzhen) Co., Ltd;; LifeScan Europe GmbH·Registered Apr 16, 2019 – Apr 16, 2029Cancelled
Registration details
Analysis ID
e1aee39bca8f1d1df7a3be20cb34d259
Customs Code
DHA05603240902
Company information
Manufacturer Country
Switzerland;;China
Authorized Representative
DKSH TAIWAN LTD.
Product details
Intended Use
This product is used to quantitatively measure glucose (blood glucose) in fresh microvascular whole blood samples obtained from fingertips. This product is intended for use by a single patient only and is not shared. This product is designed to facilitate in vitro measurement of blood glucose concentration in the home of diabetic patients (for in vitro diagnosis), and can also be used by medical staff in a clinical setting to assist in monitoring the effect of diabetes disease control. This product is not intended for the diagnosis or screening of diabetes and is not intended for use in newborns.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1345 Glucose Test System
Import Information
import
Dates and status
Registration Date
Apr 16, 2019
Expiry Date
Apr 16, 2029
Cancellation Date
Jul 08, 2024
Cancellation information
Status
Logged out
Reason
證別變更
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About this record

Access comprehensive regulatory information for Wenhao Smart Superior 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 e1aee39bca8f1d1df7a3be20cb34d259 and manufactured by Flextronics Industrial (Shenzhen) Co., Ltd;; LifeScan Europe GmbH. The authorized representative in Taiwan is DKSH TAIWAN LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Flextronics Industrial (Shenzhen) Co., Ltd;; LifeScan Europe GmbH, and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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