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"AGCO" S blood glucose test strip - Taiwan Registration 42b6f937610e39229c173a45b506690c

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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42b6f937610e39229c173a45b506690c
Registration Details
Taiwan FDA Registration: 42b6f937610e39229c173a45b506690c
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Device Details

"AGCO" S blood glucose test strip
TW: "ๆ„›็ง‘ไพ†"S ่ก€็ณ–ๆชขๆธฌ่ฉฆ็ด™
Risk Class 2

Registration Details

42b6f937610e39229c173a45b506690c

DHA05603294003

Company Information

Japan;;Korea, Republic of

Product Details

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.

A Clinical chemistry and clinical toxicology

A.1345 Glucose Test System

Input;; Contract manufacturing

Dates and Status

Oct 14, 2019

Oct 14, 2024