Taiwan FDA registration dabfe576339040ce6c6836034457142c

Smart quick blood glucose monitoring system

TW: 聰明速測血糖監測系統

Taiwan·Risk Class 2·OK BIOTECH CO., LTD.·Registered Jan 18, 2023 – Dec 10, 2025Expired

Registration details

Analysis ID: dabfe576339040ce6c6836034457142c

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 professionals or diabetics to measure blood glucose values and is not intended as a final diagnosis of diabetes.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1345 Glucose Test System
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Jan 18, 2023
Expiry Date: Dec 10, 2025

About this record

Access comprehensive regulatory information for Smart quick 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 dabfe576339040ce6c6836034457142c and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..

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