Taiwan FDA registration 42b6f937610e39229c173a45b506690c

"AGCO" S blood glucose test strip

TW: "愛科來"S 血糖檢測試紙

Taiwan·Risk Class 2·i-SENS Songdo Factory;; ARKRAY Factory, Inc.,·Registered Oct 14, 2019 – Oct 14, 2024Expired

Registration details

Analysis ID: 42b6f937610e39229c173a45b506690c
Customs Code: DHA05603294003

Company information

Manufacturer: i-SENS Songdo Factory;; ARKRAY Factory, Inc.,
Manufacturer Country: Japan;;Korea, Republic of
Authorized Representative: SYNGEN BIOTECH CO., LTD.

Product details

Intended Use: This product needs to be used with "AGLA" S blood glucose meter, which can quantitatively measure the glucose concentration in the whole blood of fingertips, palms and arm microvessels. For home or clinical assistance in monitoring blood glucose levels in diabetic patients. This product should not be used to diagnose 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: Input;; Contract manufacturing

Dates and status

Registration Date: Oct 14, 2019
Expiry Date: Oct 14, 2024

About this record

Access comprehensive regulatory information for "AGCO" S blood glucose test strip in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 42b6f937610e39229c173a45b506690c and manufactured by i-SENS Songdo Factory;; ARKRAY Factory, Inc.,. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..

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