Taiwan FDA registration 6f209297eb0faecda5984a1e3f283431

Speed test New heme monitoring system

TW: 耐速測全新血紅素監測系統

Taiwan·Risk Class 2·Nine Feather International Enterprises Limited;; Yuxin Biotechnology Co., Ltd·Registered Dec 16, 2019 – Dec 16, 2029Active

Registration details

Analysis ID: 6f209297eb0faecda5984a1e3f283431

Company information

Manufacturer: Nine Feather International Enterprises Limited;; Yuxin Biotechnology Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: KERNEL INT'L CORP.

Product details

Intended Use: 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.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.7500 Whole blood hemoglobin analysis
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Dec 16, 2019
Expiry Date: Dec 16, 2029

About this record

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..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.