Taiwan FDA registration ac2f71b030d7566cd9612404a27e2419

Corno blood glucose/cholesterol/heme monitoring system

TW: 可諾血糖/膽固醇/血紅素監測系統

Taiwan·Risk Class 2·Nine Feather International Enterprises Limited;; Yuxin Biotechnology Co., Ltd·Registered Aug 18, 2017 – Jun 13, 2026Expired

Registration details

Analysis ID: ac2f71b030d7566cd9612404a27e2419

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, measured with fresh fingertip microvascular whole blood to quantify blood sugar, cholesterol and heme content. This product can be used by self-testing and healthcare professionals, but is not intended for testing of newborns. The efficacy has been changed to: 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 Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1345 Glucose Test System;; B.7500 Heme analysis of whole blood;; A.1175 Cholesterol (Total) Testing System
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Aug 18, 2017
Expiry Date: Jun 13, 2026

About this record

Access comprehensive regulatory information for Corno blood glucose/cholesterol/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 ac2f71b030d7566cd9612404a27e2419 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.