180224
Radiofrequency Therapy Systems, Tissue Ablation
射频治疗系统,组织消融
Gynesonics, Inc.·III·Hong Kong MDACS·Registered March 03, 2023
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切萨皮克大道, 红木城, 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
- March 03, 2023
- Expiry date
- August 03, 2028
Product models
Sonata Sonography-Guided Transcervical Fibroid Ablation System (Sonata System) and Sonata System Accessories (SONATA-240, USCON-2100, RFG-240, ACCY-001, ACCY-004, IUSP-001, IUSP-001S, RFA-001, DE-001, SHPR-001, RTN-001, RTN-002, CYL-001, PE-001, CSKIT-001)
Sonata 超声引导经宫颈肌瘤消融系统(Sonata 系统)和 Sonata 系统附件(SONATA-240、USCON-2100、RFG-240、ACCY-001、ACCY-004、IUSP-001、IUSP-001S、RFA-001、DE-001、SHPR-001、RTN-001、RTN-002、CYL-001、PE-001、CSKIT-001)
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