230168
III
current
Ultrasound Therapy Systems, Tissue Ablation, Prostatic่ถ ๅฃฐๆฒป็็ณป็ปใ็ป็ปๆถ่ใๅๅ่ บ
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
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
18826
Product Code Detail
18826 Ultrasound Therapy Systems, Tissue Ablation, Prostatic
State
current
Status
N/A
Brand
Focal One System and Accessories
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Manufacturer (่ฃฝ้ ๅ)
EDAP TMS France
Edap Tms France
Parc d'Activitรฉs La Poudrette Lamartine - 4 rue du Dauphinรฉ - 69120 VAULX-EN-VELIN, FRANCE
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Authorised Representative (AR)
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)
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ๆขๅคด (TMS 902000, TMS 902081), FocalPak (EDP 901400)