Taiwan FDA registration 3969ac0236f802ec3572ed34a339026b
"Elendi" X-ray Tube Set for Diagnosis (Uninverted)
TW: "艾鎂迪" 診斷用X光球管套組件 (未滅菌)
Registration details
- Analysis ID
- 3969ac0236f802ec3572ed34a339026b
- Customs Code
- DHAS9600491106
Company information
- Manufacturer
- I.M.D. CHINA CO. LTD.
- Manufacturer Country
- China
- Authorized Representative
- LITE-MED INC.
Product details
- Intended Use
- It is limited to the first-level identification scope of the "X-ray Ball Tube Sleeve Components for Diagnosis (P.1760)" of the Measures for the Classification and Grading of Medical Devices.
- Product Type (Level 1)
- P Radiology Science
- Product Type (Level 2)
- P.1760 診斷用X光球管套組件
- Import Information
- QMS/QSD;; The consent of the Nuclear Safety Commission must be obtained for each import of this medical device.;; Input;; Chinese goods
Dates and status
- Registration Date
- Mar 21, 2024
- Expiry Date
- Mar 21, 2029
About this record
Access comprehensive regulatory information for "Elendi" X-ray Tube Set for Diagnosis (Uninverted) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 3969ac0236f802ec3572ed34a339026b and manufactured by I.M.D. CHINA CO. LTD.. The authorized representative in Taiwan is LITE-MED INC..
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