Taiwan FDA registration 7f590cf541b66ba8d00fc0430710a2c7

Deensheng blood glucose monitoring system

TW: 德恩勝血糖監測系統

Taiwan·Risk Class 2·OK BIOTECH CO., LTD.·Registered Jul 15, 2021 – Jul 15, 2026Expired

Registration details

Analysis ID: 7f590cf541b66ba8d00fc0430710a2c7

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): 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: Jul 15, 2021
Expiry Date: Jul 15, 2026

About this record

Access comprehensive regulatory information for Deensheng 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 7f590cf541b66ba8d00fc0430710a2c7 and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..

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