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Speed test New heme monitoring system - Taiwan Registration 6f209297eb0faecda5984a1e3f283431

Access comprehensive regulatory information for Speed test New heme 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 6f209297eb0faecda5984a1e3f283431 and manufactured by Nine Feather International Enterprises Limited;; Yuxin Biotechnology Co., Ltd. The authorized representative in Taiwan is KERNEL INT'L CORP..

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6f209297eb0faecda5984a1e3f283431
Registration Details
Taiwan FDA Registration: 6f209297eb0faecda5984a1e3f283431
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Device Details

Speed test New heme monitoring system
TW: ่€้€Ÿๆธฌ ๅ…จๆ–ฐ ่ก€็ด…็ด  ็›ฃๆธฌ็ณป็ตฑ
Risk Class 2

Registration Details

6f209297eb0faecda5984a1e3f283431

Company Information

Product Details

This product is for in vitro testing only to quantify heme content using fresh fingertip microvascular whole blood. This product is intended for self-testing and professional use, but is not intended for testing in newborns.

B Hematology, pathology, and genetics

B.7500 Whole blood hemoglobin analysis

Domestic;; Contract manufacturing

Dates and Status

Dec 16, 2019

Dec 16, 2029