Taiwan FDA registration e52504ddd4fba255e276e7152af82649
Bilicon Bluetooth blood glucose/blood ketone dual function test system
TW: 必立康藍牙血糖/血酮雙功能測試系統
Taiwan·Risk Class 2·APEX BIOTECHNOLOGY CORPORATION·Registered Jun 22, 2021 – Jun 22, 2026ExpiredRegistration details
- Analysis ID
- e52504ddd4fba255e276e7152af82649
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, which is used to quantitatively detect the blood glucose value of whole blood collected from fingertips, palms and forearms and detect the blood ketone value of whole blood collected from fingertips and veins, and can be used by medical staff or self-in in vitro testing.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1435 Ketone (non-quantitative) testing system;; A.1345 Glucose Test System
- Import Information
- QMS/QSD;; 國產
Dates and status
- Registration Date
- Jun 22, 2021
- Expiry Date
- Jun 22, 2026
About this record
Access comprehensive regulatory information for Bilicon Bluetooth blood glucose/blood ketone dual function test system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e52504ddd4fba255e276e7152af82649 and manufactured by APEX BIOTECHNOLOGY CORPORATION. The authorized representative in Taiwan is APEX BIOTECHNOLOGY CORPORATION.
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