Taiwan FDA registration b162e3106d27e48744ee054b59846ff6

Speed Test New blood glucose/cholesterol monitoring system

TW: 耐速測全新血糖/膽固醇監測系統

Taiwan·Risk Class 2·BIOPTIK TECHNOLOGY, INC.·Registered Jun 01, 2018 – Jun 01, 2028Active

Registration details

Analysis ID: b162e3106d27e48744ee054b59846ff6

Company information

Manufacturer: BIOPTIK TECHNOLOGY, INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: KERNEL INT'L CORP.

Product details

Intended Use: The change of efficacy is: this product is only for in vitro testing, measured with fresh fingertip microvascular whole blood to quantify blood glucose and cholesterol content, this product can be used by self-tests and professionals, but not suitable for newborn testing.
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: Contract manufacturing;; Domestic

Dates and status

Registration Date: Jun 01, 2018
Expiry Date: Jun 01, 2028

About this record

Access comprehensive regulatory information for Speed Test New 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 b162e3106d27e48744ee054b59846ff6 and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is KERNEL INT'L CORP..

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