Taiwan FDA registration 15dc50dfbfc69fad4428df9d3039d55d

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 May 10, 2024 – Apr 16, 2029Active
Registration details
Analysis ID
15dc50dfbfc69fad4428df9d3039d55d
Customs Code
DHA09200128606
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
Contract manufacturing;; Input;; Chinese goods;; QMS/QSD
Dates and status
Registration Date
May 10, 2024
Expiry Date
Apr 16, 2029
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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 15dc50dfbfc69fad4428df9d3039d55d 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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