Taiwan FDA registration 44f9c5df1db0be9f28fd33f0a3b2e204

E-Mei Advanced Blood Glucose Monitoring System

TW: 易美測進階型血糖監測系統

Taiwan·Risk Class 2·BIOPTIK TECHNOLOGY, INC.·Registered May 07, 2019 – May 07, 2029Active

Registration details

Analysis ID: 44f9c5df1db0be9f28fd33f0a3b2e204

Company information

Manufacturer: BIOPTIK TECHNOLOGY, INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: BIOPTIK TECHNOLOGY, INC.

Product details

Intended Use: This product is for in vitro testing only, using the detection of fresh fingertip microvascular whole blood to quantify blood glucose levels. This product can be used by self-testing and healthcare professionals, but is not intended for testing of newborns.
Product Type (Level 1): I General, Plastic Surgery & Dermatology;; A Clinical Chemistry and Clinical Toxicology
Product Type (Level 2): I.4800 Manual instruments for general surgery; A.1345 Glucose Test System
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: May 07, 2019
Expiry Date: May 07, 2029

About this record

Access comprehensive regulatory information for E-Mei Advanced Blood Glucose 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 44f9c5df1db0be9f28fd33f0a3b2e204 and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is BIOPTIK TECHNOLOGY, INC..

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