Taiwan FDA registration ece8b4f192c749860b19414182339375
"Simonzi" High Sensitivity Muscle Calcium Protein I Trial Set
TW: "西門子" 高敏感性肌鈣蛋白 I 試劑組
Taiwan·Risk Class 2·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Registered Aug 09, 2024 – Aug 09, 2029ActiveRegistration details
- Analysis ID
- ece8b4f192c749860b19414182339375
- Customs Code
- DHA05603709800
Company information
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Manufacturer Country
- United States
- Authorized Representative
- SIEMENS HEALTHCARE LIMITED
Product details
- Intended Use
- 本產品用於體外診斷,需搭配 Atellica IM Analyzer 或 Atellica CI Analyzer 定量檢測人血清或血漿 (肝素鋰)中的心肌肌鈣蛋白 I.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system; A.1150 calibration
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Aug 09, 2024
- Expiry Date
- Aug 09, 2029
About this record
Access comprehensive regulatory information for "Simonzi" High Sensitivity Muscle Calcium Protein I Trial Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ece8b4f192c749860b19414182339375 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.
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