241055
Radiofrequency Therapy Systems, Tissue Ablation
射频治疗系统,组织消融
Gynesonics, Inc.·III·Hong Kong MDACS·Registered September 24, 2024
Device overview
- Risk class
- III
- Product code
- 12327
- State
- current
- Status
- N/A
- Product code detail
- 12327 Radiofrequency Therapy Systems, Tissue Ablation
Manufacturer (製造商)
- Name
- Gynesonics, Inc.Gynesonics, Inc.
- Country
- United States美国
- Address
- 600 Chesapeake Drive, Redwood City, California, 94063, USA600 Chesapeake Drive, 雷德伍德城, 加利福尼亚州, 94063, 美国
Authorised representative (AR)
- Name
- IntegMed Limited英特曼有限公司
- Phone
- 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 经宫颈肌瘤消融仪 (SONATA2-220), Sonata 射频消融机机 (RFA-002), Sonata 色散电极 (DE-001, DE-001-10), Sonata 宫内超声探头 (IUSP-002)
About this record
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
產品資訊： 射频治疗系统,组织消融