Taiwan FDA registration 3c12f2272db01296eca3018b8ef03085

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

TW: "哈拉局克" 診斷用X光球管套組件 (未滅菌)

Taiwan·Risk Class 1·HOLOGIC, INC.·Registered Sep 19, 2017 – Sep 19, 2022Cancelled

Registration details

Analysis ID: 3c12f2272db01296eca3018b8ef03085
Customs Code: DHAS9401832901

Company information

Manufacturer: HOLOGIC, 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: Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); input

Dates and status

Registration Date: Sep 19, 2017
Expiry Date: Sep 19, 2022
Cancellation Date: Apr 12, 2024

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "Harabok" 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 3c12f2272db01296eca3018b8ef03085 and manufactured by HOLOGIC, INC.. The authorized representative in Taiwan is SUMTAGE ENTERPRISE CO., LTD..

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