Taiwan FDA registration 922ea8b5cc77a4dd433886dd0d997a6f

"Energizing" diagnostic X-ray tubes (unsterilized)

TW: "加能" 診斷用X光球管 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·Canon Electron Tubes & Devices Co., Ltd.·Registered Jun 25, 2019 – Jun 25, 2024Expired
Registration details
Analysis ID
922ea8b5cc77a4dd433886dd0d997a6f
Customs Code
DHAS9402058702
Company information
Manufacturer Country
Japan
Authorized Representative
ROLENCE ENTERPRISE INC.
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
Jun 25, 2019
Expiry Date
Jun 25, 2024
About this record

Access comprehensive regulatory information for "Energizing" diagnostic X-ray tubes (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 922ea8b5cc77a4dd433886dd0d997a6f and manufactured by Canon Electron Tubes & Devices Co., Ltd.. The authorized representative in Taiwan is ROLENCE ENTERPRISE INC..

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