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
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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