Taiwan FDA registration a44ff40e708eab348e455f828fa092e5
"Singularity-Yokogawa" diagnostic X-ray tube sleeve assembly (unsterilized)
TW: “奇異-橫河” 診斷用X光球管套組件(未滅菌)
Registration details
- Analysis ID
- a44ff40e708eab348e455f828fa092e5
- Customs Code
- DHAS4400116206
Company information
- Manufacturer
- GE YOKOGAWA MEDICAL SYSTEM LTD.
- Manufacturer Country
- Japan
- Authorized Representative
- GE MEDICAL SYSTEMS TAIWAN, LTD.
Product details
- Intended Use
- X-ray generating tubes enclosed in radiological protective devices for diagnostic purposes. The general form of this equipment includes high voltage and fiber optic converters or other applicable parts.
- 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
- Oct 20, 2005
- Expiry Date
- Oct 20, 2025
About this record
Access comprehensive regulatory information for "Singularity-Yokogawa" diagnostic X-ray tube sleeve assembly (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number a44ff40e708eab348e455f828fa092e5 and manufactured by GE YOKOGAWA MEDICAL SYSTEM LTD.. The authorized representative in Taiwan is GE MEDICAL SYSTEMS TAIWAN, LTD..
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