Taiwan FDA registration 40b0aa207dcc5dd1e09651b3ce338c01

Steady blood glucose test strips

TW: 穩悅血糖試紙
Taiwan flagTaiwan·Risk Class 2·LIFESCAN SCOTLAND LTD.;; LifeScan Europe GmbH·Registered Mar 06, 2018 – Mar 06, 2023Expired
Registration details
Analysis ID
40b0aa207dcc5dd1e09651b3ce338c01
Customs Code
DHA05603051504
Company information
Manufacturer Country
United Kingdom;;Switzerland
Authorized Representative
DKSH TAIWAN LTD.
Product details
Intended Use
This product needs to be used with the OneTouch Verio blood glucose monitoring system series (OneTouch VerioVue blood glucose meter), mainly for the quantitative measurement of glucose (blood glucose) on fresh fingertip microvascular whole blood. This product can provide in vitro self-test of blood glucose concentration in diabetic patients in their own homes (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. OneTouch Verio blood glucose monitoring systems are not intended for diagnosing or screening diabetes, nor are they 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
Dates and status
Registration Date
Mar 06, 2018
Expiry Date
Mar 06, 2023
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About this record

Access comprehensive regulatory information for Steady blood glucose test strips in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 40b0aa207dcc5dd1e09651b3ce338c01 and manufactured by LIFESCAN SCOTLAND LTD.;; LifeScan Europe GmbH. The authorized representative in Taiwan is DKSH TAIWAN LTD..

This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTERNATIONAL;; LIFESCAN SCOTLAND LTD., LIFESCAN SCOTLAND LTD.;; LIFESCAN EUROPE GMBH, and 3 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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