Taiwan FDA registration da9940dd775741156ad3a1364c5efe5f

BIONANO Blood Glucose Monitoring System

TW: 百優諾血糖監測系統

Taiwan·Risk Class 2·MD·OK BIOTECH CO., LTD.·Registered Feb 20, 2023 – Feb 20, 2028Active

Registration details

Analysis ID: da9940dd775741156ad3a1364c5efe5f
License Form: Ministry of Health Medical Device Manufacturing No. 007586

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 professionals or diabetic patients to measure blood glucose values and should not be used as the final judgment of diabetes.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A1345 Glucose Test System
Import Information: Produced in Taiwan, China; GMP

Dates and status

Registration Date: Feb 20, 2023
Expiry Date: Feb 20, 2028

About this record

Access comprehensive regulatory information for BIONANO 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 da9940dd775741156ad3a1364c5efe5f and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..

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