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射频治疗仪High Frequency Surgical Unit国械注进20243090144

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射频治疗仪High Frequency Surgical Unit is a Energy-based device product (Class III device), registered by VIOL.Co.,Ltd.. Linked registrations: China 国械注进20243090144. Data as of 2026-10-24.

  • Regulatory classEnergy-based device · Class III device
  • HolderVIOL.Co.,Ltd.
  • JurisdictionsCN · TW
  • Updated2026-10-24 · v1

Registration and basics are public; findings and prices need an account

Registration and basics

射频治疗仪High Frequency Surgical Unit

Product
Regulatory class
Class III device
Category
Energy-based device
China · NMPA device registration
国械注进20243090144
Registrant
维奥有限公司VIOL.Co.,Ltd.
China agent
通化济达医药有限公司
First approval
Not obtained from an official source
This certificate issued
2024-03-19
Valid until
2029-03-18
Models and sizes
SYLFIRM X
Checked against official page
2026-10-23

Public: fields from the registration record.

Label facts by jurisdiction

What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A

AttributeTaiwan label (not China-approved)
Indications颏下：用于松弛的颏下拉提; 侧腹：用于改善侧腹皮肤紧致度; 眉眼：用于眉眼拉提（eyebrow lifting）; 下腹：用于改善下腹皮肤紧致度; 大腿：用于改善大腿皮肤紧致度
Contraindications下颚缘上、下颚角：下颚缘上、下颚角水平方向各2公分的区域为非治疗区，以避开表浅神经，特别是第七脑神经－颜神经分支位置; 肿胀部位：若使用部位有肿胀，请勿使用; 请勿将该设备用于本使用手册所述以外的用途; 受损或破损皮肤：请勿在受损或破损的皮肤上使用; 新生儿、婴儿、儿童：新生儿、婴儿、儿童禁止使用; 眼睛：由于本产品发射的超声波可能会刺激眼睛，因此请避免直接接触眼睛; 请勿在发射射频能量的设备（如电外科医疗器材）附近使用本产品
Composition不适用N/A
Storage探头：探头储存环境条件：温度5℃~40℃，湿度10%RH~90%RH，大气压力700hPa~1060hPa; 储存及运输：储存及运输环境条件：温度-20℃~60℃，湿度10%RH~90%RH，大气压力700hPa~1060hPa
Shelf life无法核实（摘录对不上原文或原件无法识别）Could not verify
Injection depth不适用N/A
Recommended dose不适用N/A
Duration不适用N/A
Adverse reactions本说明书所述副作用（未报告发生率）：可能出现电击连接处略微发红、轻微疼痛、轻微头痛、瘙痒等副作用，出现时请遵照医师指示
Warnings使用本产品时需有医师的处方及指导; 使用本产品时请勿进行X光或MRI扫描；由于本产品或相应诊断设备故障，可能获得不准确的影像; 如果患者在使用本产品时感到任何不适，请停止使用; 请勿使用湿布、喷雾等进行清洁或消毒，否则可能导致本产品损坏和引起触电; 孕妇、哺乳期妇女、育龄妇女、老年人：孕妇、哺乳期妇女、育龄妇女、老年人等肌肤敏感，可能引起过敏，使用前请咨询专科医师; 身体有障碍人士：身体有障碍的人士应在具有专业使用知识的医事人员指导下使用本产品
preparation不适用N/A
storage after preparation不适用N/A

Each cell is extracted from that jurisdiction's label; click the number for the original passage. “—” means nothing has been extracted for it yet, not that the label is silent. Columns other than China reflect what was approved there, for reference only, not what China approved. 28 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20243090144 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注进20243090144 change

    延续或变更注册获批（受理号 JQX2501387；2026年07月30日医疗器械批准证明文件送达信息）

  3. CN

    国械注进20243090144 change

    官网变更：1.“生产地址：C-808,809 Bundang Technopark C, 744, Pangyo-ro, Bundang-gu Seongnam-si, Gyeonggido 13510 REPUBLIC OF KOREA”变更为“生产地址：C-608,609,8…

  4. CN

    国械注进20243090144 valid until

First approval, this certificate's issue date (updated after renewals or changes), changes and expiry are listed separately; a missing first approval means it was not obtained from an official source. Up to 6 recent changes per registration; click the number for the full record.

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Recent changes

3
  • 国械注进20243090144: 延续或变更注册获批（受理号 JQX2501387；2026年07月30日医疗器械批准证明文件送达信息）2026-07-28
  • 国械注进20243090144: 官网变更：1.“生产地址：C-808,809 Bundang Technopark C, 744, Pangyo-ro, Bundang-gu Seongnam…2026-07-28
  • 国械注进20243090144: certificate issued2024-03-19

Sources

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