Ultrasound Therapy Systems, Tissue Ablation, Prostatic

超声治疗系统、组织消融、前列腺

EDAP TMS France·III·Hong Kong MDACS·Registered May 09, 2023

Device overview

Risk class: III
Product code: 18826
State: current
Status: N/A
Brand: Focal One System and Accessories
焦点一号系统和附件
Product code detail: 18826 Ultrasound Therapy Systems, Tissue Ablation, Prostatic

Manufacturer (製造商)

Name: EDAP TMS France
Edap Tms France
Address: Parc d'Activités La Poudrette Lamartine - 4 rue du Dauphiné - 69120 VAULX-EN-VELIN, FRANCE
拉马丁活动公园 - 多芬内街 4 号 - 69120 沃克斯昂韦林, 联邦公报安斯

Authorised representative (AR)

Name: Qualtech Consulting Corporation Ltd.
Phone: 63412255

Regulatory timeline

Registration date: May 09, 2023
Expiry date: May 09, 2028

Product models

Focal One (TMS 234780), Endorectal Probe (TMS 902000, TMS 902081), FocalPak (EDP 901400)

焦点一 (TMS 234780), 直肠内探头 (TMS 902000, TMS 902081), FocalPak (EDP 901400)

About this record

This profile provides complete Hong Kong MDACS registration information for Ultrasound Therapy Systems, Tissue Ablation, Prostatic. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: Ultrasound Therapy Systems, Tissue Ablation, Prostatic

產品資訊： 超声治疗系统、组织消融、前列腺