Taiwan FDA registration 7a34d32b0b789f0de02f7adac58ed1bf

Bilikang 3-in-1 Test System (Cholesterol/Triglycerides/Uric Acid) (Non-sterilized)

TW: 必立康三合一測試系統(膽固醇/三酸甘油脂/尿酸) (未滅菌)

Taiwan·Risk Class 1·APEX BIOTECHNOLOGY CORPORATION·Registered Mar 15, 2024 – Mar 15, 2029Active

Registration details

Analysis ID: 7a34d32b0b789f0de02f7adac58ed1bf

Company information

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

Product details

Intended Use: It is limited to the first level identification scope of the "Cholesterol (Total) Test System (A.1175)", "Triglyceride Test System (A.1705)" and "Uric Acid Test System (A.1775)" of the Classification and Grading Management Measures for Medical Devices.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1775 Uric acid testing system;; A.1705 Triglyceride test system;; A.1175 Cholesterol (Total) Testing System
Import Information: QMS/QSD;; 國產

Dates and status

Registration Date: Mar 15, 2024
Expiry Date: Mar 15, 2029

About this record

Access comprehensive regulatory information for Bilikang 3-in-1 Test System (Cholesterol/Triglycerides/Uric Acid) (Non-sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 7a34d32b0b789f0de02f7adac58ed1bf and manufactured by APEX BIOTECHNOLOGY CORPORATION. The authorized representative in Taiwan is APEX BIOTECHNOLOGY CORPORATION.

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