Taiwan FDA registration 5d44a1e4026fcf9150d4c5cd18468abb
"Deere Guard" Diagnostic X-ray Tube Set (Uninverted)
TW: "迪爾駿" 診斷用X光球管套組件 (未滅菌)
Taiwan·Risk Class 1·DGREM Corporation·Registered Aug 23, 2024 – Aug 23, 2029ActiveRegistration details
- Analysis ID
- 5d44a1e4026fcf9150d4c5cd18468abb
- Customs Code
- DHAS9402358000
Company information
- Manufacturer
- DGREM Corporation
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- FUJIFILM HEALTHCARE TAIWAN CO., LTD.
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
- The consent of the Nuclear Safety Commission must be obtained for each import of this medical device.;; QMS/QSD;; input
Dates and status
- Registration Date
- Aug 23, 2024
- Expiry Date
- Aug 23, 2029
About this record
Access comprehensive regulatory information for "Deere Guard" Diagnostic X-ray Tube Set (Uninverted) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 5d44a1e4026fcf9150d4c5cd18468abb and manufactured by DGREM Corporation. The authorized representative in Taiwan is FUJIFILM HEALTHCARE TAIWAN CO., LTD..
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