Taiwan FDA registration e270c84a45ea12716df345653c5a2755

Oak Measurement Blood Glucose Monitoring System

TW: 歐克測優血糖監測系統

Taiwan·Risk Class 2·OK BIOTECH CO., LTD.·Registered Aug 24, 2021 – Aug 24, 2026Active

Registration details

Analysis ID: e270c84a45ea12716df345653c5a2755

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

Dates and status

Registration Date: Aug 24, 2021
Expiry Date: Aug 24, 2026

About this record

Access comprehensive regulatory information for Oak Measurement 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 e270c84a45ea12716df345653c5a2755 and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..

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