Taiwan FDA registration 464fb388c8af4edf4c500567b39c97e7

Steady blood glucose test strips

TW: 穩睿血糖試紙
Taiwan flagTaiwan·Risk Class 2·LIFESCAN SCOTLAND LTD.;; LIFESCAN EUROPE GMBH·Registered Jun 20, 2016 – Jun 20, 2026Expired
Registration details
Analysis ID
464fb388c8af4edf4c500567b39c97e7
Customs Code
DHA05602844606
Company information
Manufacturer Country
United Kingdom;;Switzerland
Authorized Representative
DKSH TAIWAN LTD.
Product details
Intended Use
This product is used with the OneTouch Select Plus series blood glucose monitoring system (OneTouch Select Plus, OneTouch Select Plus Flex) to quantitatively measure glucose (blood glucose) in fresh microvascular whole blood samples taken from fingertips. The blood glucose monitoring systems of the OneTouch Select Plus series are for a single patient only and should not be shared. The blood glucose monitoring systems of the OneTouch Select Plus series are not intended for the diagnosis or screening of diabetes, nor should they be used in newborns.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1345 Glucose Test System
Import Information
Input;; Contract manufacturing
Dates and status
Registration Date
Jun 20, 2016
Expiry Date
Jun 20, 2026
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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 464fb388c8af4edf4c500567b39c97e7 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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