Taiwan FDA registration 9452c03040b8b3faa98f2f72529c69a8

Oak Health Blood Glucose Monitoring System

TW: 歐克健康血糖監測系統

Taiwan·Risk Class 2·OK BIOTECH CO., LTD.·Registered Apr 17, 2020 – Apr 17, 2025Expired

Registration details

Analysis ID: 9452c03040b8b3faa98f2f72529c69a8

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 values of fingertips and other blood collection sites (palm, forearm, upper arm, calf and thigh) microvascular whole blood and arm veins, and is not suitable for neonatal testing.
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: Domestic

Dates and status

Registration Date: Apr 17, 2020
Expiry Date: Apr 17, 2025

About this record

Access comprehensive regulatory information for Oak Health 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 9452c03040b8b3faa98f2f72529c69a8 and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..

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