Taiwan FDA registration 4a1128897dc1048bf636acf49859a4ef

Corno blood glucose/heme monitoring system

TW: 可諾血糖/血紅素監測系統

Taiwan·Risk Class 2·Nine Feather International Enterprises Limited;; Yuxin Biotechnology Co., Ltd·Registered Aug 30, 2017 – Sep 06, 2026Active

Registration details

Analysis ID: 4a1128897dc1048bf636acf49859a4ef

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 only for in vitro testing, and the blood glucose and heme content are quantified by measuring fresh fingertip microvascular whole blood. This product can be used by self-testing and healthcare professionals, but is not intended for testing of newborns. This product is only for in vitro testing, and the blood glucose and heme content are quantified by measuring fresh fingertip microvascular whole blood. This product is intended for professional use only, but is not intended for testing of newborns.
Product Type (Level 1): B Hematology, Pathology and Genetics;; A Clinical Chemistry and Clinical Toxicology;; I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4800 Manual instruments for general surgery; A.1345 Glucose Test System;; B.7500 Heme analysis of whole blood
Import Information: Contract manufacturing;; Domestic

Dates and status

Registration Date: Aug 30, 2017
Expiry Date: Sep 06, 2026

About this record

Access comprehensive regulatory information for Corno blood glucose/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 4a1128897dc1048bf636acf49859a4ef 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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