Taiwan FDA registration 9804762b8de0adeedc5deed421d5e055

"Haraquik" prone mammogram system

TW: “哈拉局克”俯臥式乳房X光切片檢查系統
Taiwan flagTaiwan·Risk Class 2·HOLOGIC, INC.·Registered Oct 26, 2017 – Oct 26, 2027Active
Registration details
Analysis ID
9804762b8de0adeedc5deed421d5e055
Customs Code
DHAS5603040100
Company information
Manufacturer
HOLOGIC, INC.
Manufacturer Country
United States
Authorized Representative
SUMTAGE ENTERPRISE CO., LTD.
Product details
Intended Use
For details, it is Chinese approved copy of the imitation order
Product Type (Level 1)
P Radiology Science
Product Type (Level 2)
P.1710 乳房X光系統
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 26, 2017
Expiry Date
Oct 26, 2027
About this record

Access comprehensive regulatory information for "Haraquik" prone mammogram system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9804762b8de0adeedc5deed421d5e055 and manufactured by HOLOGIC, INC.. The authorized representative in Taiwan is SUMTAGE ENTERPRISE CO., LTD..

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