Taiwan FDA registration 4703ffbbff9b083a4823d9997439d870

Gardack blood glucose monitoring system

TW: 嘉達克血糖監測系統

Taiwan·Risk Class 2·OK BIOTECH CO., LTD.·Registered Jul 15, 2021 – Jul 15, 2026Expired

Registration details

Analysis ID: 4703ffbbff9b083a4823d9997439d870

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): 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: Jul 15, 2021
Expiry Date: Jul 15, 2026

About this record

Access comprehensive regulatory information for Gardack 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 4703ffbbff9b083a4823d9997439d870 and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..

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