Taiwan FDA registration a0b38cbe7081681866c5eba8f7021862

Glucosa-sensitive glucose monitoring system

TW: 葡升敏血糖監測系統

Taiwan·Risk Class 2·OK BIOTECH CO., LTD.·Registered Jun 15, 2021 – Dec 10, 2025Expired

Registration details

Analysis ID: a0b38cbe7081681866c5eba8f7021862

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;; I General, Plastic Surgery and Dermatology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical); I.4800 Surgical Hand Instruments for General Surgery;; A.1345 Glucose test system
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Jun 15, 2021
Expiry Date: Dec 10, 2025

About this record

Access comprehensive regulatory information for Glucosa-sensitive 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 a0b38cbe7081681866c5eba8f7021862 and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.