"Sonar Care" high-intensity focused ultrasound ablation system - Taiwan Registration 044f9d6125b3d0032dc8c9713f88b1d5
Access comprehensive regulatory information for "Sonar Care" high-intensity focused ultrasound ablation system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 044f9d6125b3d0032dc8c9713f88b1d5 and manufactured by Focus Surgery, Inc.;; Sonablate Corp.. The authorized representative in Taiwan is TOP GEAL CO., LTD..
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Device Details
Product Details
High-intensity focused ultrasound (HIFU) is used to ablate prostate (prostate) tissue. The scope of application includes: local primary prostate (prostate) cancer, local recurrent prostate (prostate) cancer. (Gleeson score 6-9, stage T1c-3bN0M0, and prostate-specific antigen less than or equal to 30ng/ml)
I General, Plastic Surgery and Dermatology
I.0009 High-intensity focused ultrasound system
import
Dates and Status
Feb 23, 2020
Feb 23, 2030