Taiwan FDA registration 18d547c6a91538de4bc3208658b0fdcb

Oak unlimited blood glucose monitoring system

TW: 歐克無限血糖監測系統

Taiwan·Risk Class 2·OK BIOTECH CO., LTD.·Registered Mar 03, 2023 – Aug 24, 2026Active

Registration details

Analysis ID: 18d547c6a91538de4bc3208658b0fdcb

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 fingertips and other blood collection sites (palm, forearm, upper arm, calf and thigh) microvascular whole blood, 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: QMS/QSD;; 國產

Dates and status

Registration Date: Mar 03, 2023
Expiry Date: Aug 24, 2026

About this record

Access comprehensive regulatory information for Oak unlimited 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 18d547c6a91538de4bc3208658b0fdcb and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..

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