Taiwan FDA registration 38ce02775cc2597b77b47c2bcc24e114
"Rex" diagnostic X-ray tube sleeve (unsterilized)
TW: "瑞克斯"診斷用X光球管套組 (未滅菌)
Taiwan·Risk Class 1·VAREX IMAGING CORPORATION·Registered Jul 10, 2019 – Jul 10, 2029ActiveRegistration details
- Analysis ID
- 38ce02775cc2597b77b47c2bcc24e114
- Customs Code
- DHAS9402063102
Company information
- Manufacturer
- VAREX IMAGING CORPORATION
- Manufacturer Country
- United States
- Authorized Representative
- FUJIFILM HEALTHCARE TAIWAN CO., 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
- 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
- Jul 10, 2019
- Expiry Date
- Jul 10, 2029
About this record
Access comprehensive regulatory information for "Rex" diagnostic X-ray tube sleeve (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 38ce02775cc2597b77b47c2bcc24e114 and manufactured by VAREX IMAGING CORPORATION. The authorized representative in Taiwan is FUJIFILM HEALTHCARE TAIWAN CO., LTD..
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