Taiwan FDA registration 303751de89509350bbd802235f66a49e

New speed speed test Bluetooth blood glucose test piece

TW: 新速利測藍牙血糖測試片

Taiwan·Risk Class 2·APEX BIOTECHNOLOGY CORPORATION·Registered Mar 09, 2022 – Mar 09, 2027Active

Registration details

Analysis ID: 303751de89509350bbd802235f66a49e

Company information

Manufacturer: APEX BIOTECHNOLOGY CORPORATION
Manufacturer Country: Taiwan, Province of China
Authorized Representative: APEX BIOTECHNOLOGY CORPORATION

Product details

Intended Use: This product is an in vitro diagnostic medical device that provides diabetic patients and professional medical staff to measure and monitor blood glucose values. Quantitative detection of the blood glucose value of microvascular whole blood collected by fingertips, palms and arms needs to be used with the new Bluetooth blood glucose test system (model: BGM032), which is not suitable for neonatal testing.
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: Mar 09, 2022
Expiry Date: Mar 09, 2027

About this record

Access comprehensive regulatory information for New speed speed test Bluetooth blood glucose test piece in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 303751de89509350bbd802235f66a49e and manufactured by APEX BIOTECHNOLOGY CORPORATION. The authorized representative in Taiwan is APEX BIOTECHNOLOGY CORPORATION.

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