Taiwan FDA registration 406a7fd2015683f7beaf441fc831806b

"Sirui" diagnostic X-ray tube sleeve assembly (unsterilized)

TW: “思瑞”診斷用X光球管套組件 (未滅菌）

Taiwan·Risk Class 1·SOURCE-RAY, INC.·Registered Feb 08, 2011 – Feb 08, 2016Cancelled

Registration details

Analysis ID: 406a7fd2015683f7beaf441fc831806b
Customs Code: DHAS4400989409

Company information

Manufacturer: SOURCE-RAY, INC.
Manufacturer Country: United States
Authorized Representative: SUMTAGE ENTERPRISE CO., LTD.

Product details

Intended Use: Limited to the first-level identification range of the Measures for the Administration of Medical Devices "X-ray Tube Sleeve Components for Diagnosis (P.1760)".
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: Feb 08, 2011
Expiry Date: Feb 08, 2016
Cancellation Date: Jul 31, 2018

Cancellation information

Status: Logged out
Reason: 未展延而逾期者

About this record

Access comprehensive regulatory information for "Sirui" 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 406a7fd2015683f7beaf441fc831806b and manufactured by SOURCE-RAY, INC.. The authorized representative in Taiwan is SUMTAGE ENTERPRISE CO., LTD..

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