Taiwan FDA registration 820c0de70f4f3bce966a4166b350fa34

Rapid glucose monitoring system

TW: 速倍測血糖監測系統

Taiwan·Risk Class 2·OK BIOTECH CO., LTD.·Registered Dec 10, 2020 – Dec 10, 2025Expired

Registration details

Analysis ID: 820c0de70f4f3bce966a4166b350fa34

Company information

Manufacturer: OK BIOTECH CO., LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: OK BIOTECH CO., LTD.

Product details

Intended Use: This product is only for in vitro testing, quantitatively detecting the blood glucose value of fresh microvascular whole blood from fingertips and other blood collection sites (palm, forearm, upper arm, calf and thigh), and is not suitable for neonatal testing. This product can be used by professional medical professionals or diabetic patients to measure blood glucose levels, and is not intended as the final diagnosis of diabetes.
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: QMS/QSD;; 國產

Dates and status

Registration Date: Dec 10, 2020
Expiry Date: Dec 10, 2025

About this record

Access comprehensive regulatory information for Rapid 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 820c0de70f4f3bce966a4166b350fa34 and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..

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