241055
III
current
Radiofrequency Therapy Systems, Tissue Ablationๅฐ้ขๆฒป็็ณป็ป,็ป็ปๆถ่
This profile provides complete Hong Kong MDACS registration information for Radiofrequency Therapy Systems, Tissue Ablation. 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: Radiofrequency Therapy Systems, Tissue Ablation
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
12327
Product Code Detail
12327 Radiofrequency Therapy Systems, Tissue Ablation
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Gynesonics, Inc.
Gynesonics, Inc.
United States
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600 Chesapeake Drive, Redwood City, California, 94063, USA
600 Chesapeake Drive, ้ทๅพทไผๅพทๅ, ๅ ๅฉ็ฆๅฐผไบๅท, 94063, ็พๅฝ
Authorised Representative (AR)
IntegMed Limited
่ฑ็นๆผๆ้ๅ
ฌๅธ
35273026
Regulatory Timeline
Registration Date
September 24, 2024
Expiry Date
September 23, 2029
Product Models
Sonata Transcervical Fibroid Ablation System (SONATA2-220), Sonata Radiofrequency Ablation Handpiece (RFA-002), Sonata Dispersive Electrode (DE-001, DE-001-10), Sonata Intrauterine Ultrasound Probe (IUSP-002)
Sonata ็ปๅฎซ้ข่็คๆถ่ไปช (SONATA2-220), Sonata ๅฐ้ขๆถ่ๆบๆบ (RFA-002), Sonata ่ฒๆฃ็ตๆ (DE-001, DE-001-10), Sonata ๅฎซๅ
่ถ
ๅฃฐๆขๅคด (IUSP-002)