Taiwan FDA registration 9061dbcda869a9e20f55240d7ae1ba35
Beta-hydroxybutyric acid test system "Stanbiyoul" (unsterilized)
TW: “斯坦必優”貝塔-羥基丁酸測試系統(未滅菌)
Taiwan·Risk Class 1·STANBIO LABORATORY·Registered Jun 13, 2019 – Jun 13, 2029ActiveRegistration details
- Analysis ID
- 9061dbcda869a9e20f55240d7ae1ba35
- Customs Code
- DHA09402055109
Company information
- Manufacturer
- STANBIO LABORATORY
- Manufacturer Country
- United States
- Authorized Representative
- AMESDATA BIOTECH CO., LTD.
Product details
- Intended Use
- It is limited to the first level of identification scope of the "Quality Control Materials (Analytical and Non-Analytical) (A.1660)" and "Ketone (Non-quantitative) Test System (A.1435)" of the Medical Device Classification and Grading Management Measures.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1435 Ketone (non-quantitative) test system;; A.1660 Quality control materials (analytical and non-analytical)
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Jun 13, 2019
- Expiry Date
- Jun 13, 2029
About this record
Access comprehensive regulatory information for Beta-hydroxybutyric acid test system "Stanbiyoul" (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 9061dbcda869a9e20f55240d7ae1ba35 and manufactured by STANBIO LABORATORY. The authorized representative in Taiwan is AMESDATA BIOTECH CO., LTD..
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