Taiwan FDA registration 11597bc091da1e0fbb52d2c5d411d768

"Hologic" digital mammography computer-aided detection application

TW: “豪洛捷” 數位乳房攝影電腦輔助偵測應用軟體
Taiwan flagTaiwan·Risk Class 2·Hologic, Inc.·Registered Jun 26, 2023 – Jun 26, 2028Active
Registration details
Analysis ID
11597bc091da1e0fbb52d2c5d411d768
Customs Code
DHA05603655303
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.2050 Medical image management and processing systems
Import Information
import
Dates and status
Registration Date
Jun 26, 2023
Expiry Date
Jun 26, 2028
About this record

Access comprehensive regulatory information for "Hologic" digital mammography computer-aided detection application in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 11597bc091da1e0fbb52d2c5d411d768 and manufactured by Hologic, Inc.. The authorized representative in Taiwan is QUALTECH CONSULTING CORPORATION.

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