Taiwan FDA registration 41f9eb919a7fcfcfffb36ab0348bd06f

Steady Blood Glucose Monitoring System

TW: 穩睿至安血糖監測系統

Taiwan·Risk Class 2·Flextronics Industrial (Shenzhen) Co., Ltd;; LifeScan Europe GmbH·Registered Aug 24, 2021 – Feb 02, 2028Active

Registration details

Analysis ID: 41f9eb919a7fcfcfffb36ab0348bd06f
Customs Code: DHA09200128109

Company information

Manufacturer: Flextronics Industrial (Shenzhen) Co., Ltd;; LifeScan Europe GmbH
Manufacturer Country: Switzerland;;China
Authorized Representative: DKSH TAIWAN LTD.

Product details

Intended Use: Used to quantitatively measure glucose (blood glucose) in fresh microvascular whole blood samples taken from fingertips. This system is intended for use by a single patient only and should not be shared. The system is designed to provide in vitro measurement of blood glucose concentrations in the home of diabetics (for in vitro diagnostics) and can also be used by healthcare professionals in clinical settings to assist in monitoring the effectiveness of diabetes control. This system is not intended for the diagnosis or screening of diabetes, nor is it 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: Input;; QMS/QSD;; Chinese goods;; Contract manufacturing

Dates and status

Registration Date: Aug 24, 2021
Expiry Date: Feb 02, 2028

About this record

Access comprehensive regulatory information for Steady 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 41f9eb919a7fcfcfffb36ab0348bd06f and manufactured by Flextronics Industrial (Shenzhen) Co., Ltd;; LifeScan Europe GmbH. The authorized representative in Taiwan is DKSH TAIWAN LTD..

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