Taiwan FDA registration 044f9d6125b3d0032dc8c9713f88b1d5

"Sonar Care" high-intensity focused ultrasound ablation system

TW: “聲納照護”高強度聚焦超音波消融系統

Taiwan·Risk Class 3·Focus Surgery, Inc.;; Sonablate Corp.·Registered Feb 23, 2020 – Feb 23, 2030Active

Registration details

Analysis ID: 044f9d6125b3d0032dc8c9713f88b1d5
Customs Code: DHA05603298002

Company information

Manufacturer: Focus Surgery, Inc.;; Sonablate Corp.
Manufacturer Country: United States
Authorized Representative: TOP GEAL CO., LTD.

Product details

Intended Use: 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)
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.0009 High-intensity focused ultrasound system
Import Information: import

Dates and status

Registration Date: Feb 23, 2020
Expiry Date: Feb 23, 2030

About this record

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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