Taiwan FDA registration a37b3272bdccec1157350478793da52b
Cyclon 3-in-1 multifunctional monitoring system for blood glucose/cholesterol/uric acid
TW: 預爾康三合一 血糖/膽固醇/尿酸多功能監測系統
Taiwan·Risk Class 2·BIOPTIK TECHNOLOGY, INC.·Registered May 22, 2014 – Mar 05, 2029ActiveRegistration details
- Analysis ID
- a37b3272bdccec1157350478793da52b
Company information
- Manufacturer
- BIOPTIK TECHNOLOGY, INC.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- IN4 TECHNOLOGY CORPORATION
Product details
- Intended Use
- This product is for in vitro testing only, measured with fresh fingertip microvascular whole blood to quantify blood sugar, cholesterol and uric acid. This product can be used by self-testing and healthcare professionals, but is not intended for testing of newborns.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1775 Uric acid testing system;; A.1345 Glucose Test System;; A.1175 Cholesterol (Total) Testing System
- Import Information
- Contract manufacturing;; Domestic
Dates and status
- Registration Date
- May 22, 2014
- Expiry Date
- Mar 05, 2029
About this record
Access comprehensive regulatory information for Cyclon 3-in-1 multifunctional monitoring system for blood glucose/cholesterol/uric acid in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a37b3272bdccec1157350478793da52b and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is IN4 TECHNOLOGY CORPORATION.
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