Taiwan FDA registration 8009a13112752daa7642c625eba7183c

Xinshu Ding Quasi-blood glucose test tablets

TW: 欣舒測鼎準血糖測試片

Taiwan·Risk Class 2·APEX BIOTECHNOLOGY CORPORATION·Registered Jun 06, 2023 – Jun 06, 2028Active

Registration details

Analysis ID: 8009a13112752daa7642c625eba7183c

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 patients and professionals to measure and monitor blood glucose values. Quantitative detection of blood glucose values of microvascular whole blood, venous whole blood, arterial whole blood and neonatal whole blood collected from fingertips, palms and forearms, needs to be used with Xinshu Ding quasi-blood glucose test system (model: BGM033A/BGM033B), and the display is set to plasma blood glucose value (automatically corrected by the machine).
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1345 Glucose Test System
Import Information: QMS/QSD;; 國產

Dates and status

Registration Date: Jun 06, 2023
Expiry Date: Jun 06, 2028

About this record

Access comprehensive regulatory information for Xinshu Ding Quasi-blood glucose test tablets in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8009a13112752daa7642c625eba7183c and manufactured by APEX BIOTECHNOLOGY CORPORATION. The authorized representative in Taiwan is APEX BIOTECHNOLOGY CORPORATION.

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