Taiwan FDA registration ef3c3ed9f8e4651f7c9f7734b9ce5500

Speed Test New blood glucose/heme monitoring system

TW: 耐速測全新血糖/血紅素監測系統

Taiwan·Risk Class 2·BIOPTIK TECHNOLOGY, INC.·Registered Jun 14, 2018 – Jun 14, 2028Active

Registration details

Analysis ID: ef3c3ed9f8e4651f7c9f7734b9ce5500

Company information

Manufacturer: BIOPTIK TECHNOLOGY, INC.
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 quantitatively detected by fresh fingertip microvascular whole blood. This product can be used by self-testing and professionals, 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
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Jun 14, 2018
Expiry Date: Jun 14, 2028

About this record

Access comprehensive regulatory information for Speed Test New 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 ef3c3ed9f8e4651f7c9f7734b9ce5500 and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is KERNEL INT'L CORP..

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