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Ecome blood glucose/blood ketone monitoring system - Taiwan Registration 35ee4f4eae418b94bffb58289a5d5727

Access comprehensive regulatory information for Ecome blood glucose/blood ketone monitoring system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 35ee4f4eae418b94bffb58289a5d5727 and manufactured by Naohara Biotechnology Co., Ltd.;; Yuxin Biotechnology Co., Ltd. The authorized representative in Taiwan is EASY LIFE GREEN TECHNOLOGY CORPORATION.

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35ee4f4eae418b94bffb58289a5d5727
Registration Details
Taiwan FDA Registration: 35ee4f4eae418b94bffb58289a5d5727
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Device Details

Ecome blood glucose/blood ketone monitoring system
TW: ๆ˜“ๅบท ่ก€็ณ–/่ก€้…ฎ ็›ฃๆธฌ็ณป็ตฑ
Risk Class 2

Registration Details

35ee4f4eae418b94bffb58289a5d5727

Company Information

Product Details

This product is only suitable for in vitro diagnosis, using fresh fingertip microvascular whole blood to measure and quantitatively detect blood glucose and blood ketone content. This product can be used by self-testing and professionals, but is not intended for testing of newborns.

A Clinical chemistry and clinical toxicology

A.1435 Ketone (non-quantitative) testing system;; A.1345 Glucose Test System

QMS/QSD;; ๅง”่จ—่ฃฝ้€ ;; ๅœ‹็”ข

Dates and Status

Oct 17, 2023

Mar 24, 2028