Taiwan FDA registration b614428bd778c248dc69f9c1a6a272e8

Corno blood glucose/cholesterol monitoring system

TW: 可諾 血糖/膽固醇 監測系統
Taiwan flagTaiwan·Risk Class 2·BIOPTIK TECHNOLOGY, INC.·Registered Mar 08, 2021 – Jan 20, 2026Expired
Registration details
Analysis ID
b614428bd778c248dc69f9c1a6a272e8
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
KERNEL INT'L CORP.
Product details
Intended Use
This product is only suitable for in vitro diagnosis, and the blood glucose and cholesterol content are quantified by measuring fresh fingertip microvascular whole blood. This product is intended for single use only, but is not intended for testing of newborns.
Product Type (Level 1)
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;; A.1175 Cholesterol (Total) Testing System
Import Information
委託製造;; 國產;; QMS/QSD
Dates and status
Registration Date
Mar 08, 2021
Expiry Date
Jan 20, 2026
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About this record

Access comprehensive regulatory information for Corno blood glucose/cholesterol 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 b614428bd778c248dc69f9c1a6a272e8 and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is KERNEL INT'L CORP..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Nine Feather International Enterprises Limited;; Yuxin Biotechnology Co., Ltd, and 1 recent registrations in the same category. 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.

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