Taiwan FDA registration f1b21eff0f77abd284c660e0b18182f8

Kangyan Parker blood glucose monitoring system

TW: 康揚派克血糖監測系統

Taiwan·Risk Class 2·OK BIOTECH CO., LTD.·Registered Oct 08, 2021 – Oct 08, 2026Active

Registration details

Analysis ID: f1b21eff0f77abd284c660e0b18182f8

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;; I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4800 Manual instruments for general surgery; A.1345 Glucose Test System
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Oct 08, 2021
Expiry Date: Oct 08, 2026

About this record

Access comprehensive regulatory information for Kangyan Parker 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 f1b21eff0f77abd284c660e0b18182f8 and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..

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