Radiofrequency Therapy Systems, Tissue Ablation射频治疗系统,组织消融

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

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

DJ Fang

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Pricing

Manufacturer (製造商)

Gynesonics, Inc.

United States

美国

600 Chesapeake Drive, Redwood City, California 94063, USA

600切萨皮克大道, 红木城, 加利福尼亚州 94063, 美国

Authorised Representative (AR)

IntegMed Limited

英特曼有限公司

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)