Taiwan FDA registration 324cc63a32d9a96fbaf6d71bd5c74904

Stable and intelligent blood glucose test strips

TW: 穩豪智優型血糖試紙

Taiwan·Risk Class 2·LIFESCAN SCOTLAND LTD.;; LIFESCAN EUROPE GMBH·Registered Feb 22, 2019 – Feb 22, 2029Active

Registration details

Analysis ID: 324cc63a32d9a96fbaf6d71bd5c74904
Customs Code: DHA05603217809

Company information

Manufacturer: LIFESCAN SCOTLAND LTD.;; LIFESCAN EUROPE GMBH
Manufacturer Country: United Kingdom;;Switzerland
Authorized Representative: DKSH TAIWAN LTD.

Product details

Intended Use: This product must be used in conjunction with the OneTouch Ultra Plus Flex series of blood glucose monitoring systems for the quantitative measurement of glucose (blood glucose) in fresh microvascular whole blood obtained from fingertips. The OneTouch Ultra Plus family of blood glucose monitoring systems is not intended for diabetes diagnosis or screening, 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: import

Dates and status

Registration Date: Feb 22, 2019
Expiry Date: Feb 22, 2029

About this record

Access comprehensive regulatory information for Stable and intelligent 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 324cc63a32d9a96fbaf6d71bd5c74904 and manufactured by LIFESCAN SCOTLAND LTD.;; LIFESCAN EUROPE GMBH. The authorized representative in Taiwan is DKSH TAIWAN LTD..

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