Taiwan FDA registration 5c137dae9f58dc5512c6118d560cdffd

Portuguese blood glucose monitoring system

TW: 葡立測血糖監測系統

Taiwan·Risk Class 2·OK BIOTECH CO., LTD.·Registered Oct 18, 2021 – Oct 18, 2026Active

Registration details

Analysis ID: 5c137dae9f58dc5512c6118d560cdffd

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: Oct 18, 2021
Expiry Date: Oct 18, 2026

About this record

Access comprehensive regulatory information for Portuguese 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 5c137dae9f58dc5512c6118d560cdffd and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..

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