Taiwan FDA registration 48a41fcb5723b4293ed12186cf50c524
"Strange" Diagnostic X-ray Tube Sleeve Assembly (Non-sterile)
TW: 〝奇異〞 診斷用X光球管套組件 (未滅菌)
Taiwan·Risk Class 1·GE Hualun Medical Systems Co., Ltd.·Registered Aug 15, 2023 – Aug 15, 2028ActiveRegistration details
- Analysis ID
- 48a41fcb5723b4293ed12186cf50c524
- Customs Code
- DHAS9600481102
Company information
- Manufacturer
- GE Hualun Medical Systems Co., Ltd.
- Manufacturer Country
- China
- Authorized Representative
- GE MEDICAL SYSTEMS TAIWAN, LTD.
Product details
- Intended Use
- Limited to the first level identification range of the "X-ray tube sleeve assembly for diagnosis (P.1760)" of the Measures for the Classification and Grading Management of Medical Equipment.
- 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
- Chinese goods;; QMS/QSD;; Input;; Consent letter must be attached to the import (consent from the Atomic Energy Commission must be obtained for each import)
Dates and status
- Registration Date
- Aug 15, 2023
- Expiry Date
- Aug 15, 2028
About this record
Access comprehensive regulatory information for "Strange" Diagnostic X-ray Tube Sleeve Assembly (Non-sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 48a41fcb5723b4293ed12186cf50c524 and manufactured by GE Hualun Medical Systems Co., Ltd.. The authorized representative in Taiwan is GE MEDICAL SYSTEMS TAIWAN, LTD..
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