Taiwan FDA registration b8125fa9f6432eb2c263836f249d6f9c

"Haraquank" digital breast image processing software

TW: “哈拉局克”數位乳房影像處理軟體
Taiwan flagTaiwan·Risk Class 2·HOLOGIC, INC.·Registered Feb 21, 2018 – Feb 21, 2028Active
Registration details
Analysis ID
b8125fa9f6432eb2c263836f249d6f9c
Customs Code
DHA05603074100
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.2050 Medical image management and processing systems; P.1710 Mammography system
Import Information
import
Dates and status
Registration Date
Feb 21, 2018
Expiry Date
Feb 21, 2028
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About this record

Access comprehensive regulatory information for "Haraquank" digital breast image processing software in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b8125fa9f6432eb2c263836f249d6f9c and manufactured by HOLOGIC, INC.. The authorized representative in Taiwan is SUMTAGE ENTERPRISE CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including HOLOGIC, INC., and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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