Taiwan FDA registration 1960b3f8dfde81ba0f8380dd85393761
"Hologier" mammogram X-ray system
TW: “豪洛捷”乳房攝影X光系統
Taiwan·Risk Class 2·Hologic, Inc.·Registered Jun 10, 2022 – Jun 10, 2027ActiveRegistration details
- Analysis ID
- 1960b3f8dfde81ba0f8380dd85393761
- Customs Code
- DHAS5603544901
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
- 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
- Jun 10, 2022
- Expiry Date
- Jun 10, 2027
About this record
Access comprehensive regulatory information for "Hologier" mammogram X-ray system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1960b3f8dfde81ba0f8380dd85393761 and manufactured by Hologic, Inc.. The authorized representative in Taiwan is QUALTECH CONSULTING CORPORATION.
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