Taiwan FDA registration bc54e1e2e33c9155b7f6eeaa98e2e83d
"Holothi" mammogram system
TW: “豪洛捷”乳房X光切片檢查系統
Taiwan·Risk Class 2·Hologic, Inc.·Registered Dec 01, 2021 – Dec 01, 2026ActiveRegistration details
- Analysis ID
- bc54e1e2e33c9155b7f6eeaa98e2e83d
- Customs Code
- DHAS5603504401
Company information
- Manufacturer
- Hologic, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- QUALTECH CONSULTING CORPORATION
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- P Radiology Science
- Product Type (Level 2)
- P.1710 乳房X光系統
- 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
- Dec 01, 2021
- Expiry Date
- Dec 01, 2026
About this record
Access comprehensive regulatory information for "Holothi" 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 bc54e1e2e33c9155b7f6eeaa98e2e83d and manufactured by Hologic, Inc.. The authorized representative in Taiwan is QUALTECH CONSULTING CORPORATION.
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