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射频治疗仪High Frequency Device国械注进20213090309

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射频治疗仪High Frequency Device is a Energy-based device product (Class III device), registered by BTL Industries Limited. Linked registrations: China 国械注进20213090309. Data as of 2026-10-23.

  • Regulatory classEnergy-based device · Class III device
  • HolderBTL Industries Limited
  • JurisdictionsCN · TW
  • Updated2026-10-23 · v1

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

Registration and basics

射频治疗仪High Frequency Device

Product
Regulatory class
Class III device
Category
Energy-based device
China · NMPA device registration
国械注进20213090309
Registrant
BTL实业有限公司BTL Industries Limited
China agent
比特乐医疗器械（深圳）有限公司
First approval
Not obtained from an official source
This certificate issued
2021-08-06
Valid until
2026-08-05
Models and sizes
Exilis Elite
Checked against official page
Not yet checked field by field against the live official page

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肌肉、肌腱或关节：各种肌肉、肌腱或关节病变引起的疼痛缓解；不建议在新生儿、婴儿和儿童中使用; 局部生物组织：局部伤口加速愈合及缓解疼痛；不建议在新生儿、婴儿和儿童中使用
Contraindications发烧、严重疾病、慢性感染; 癫痫; 治疗区域：最近三个月内治疗区域有皮质类固醇注射、长期使用皮质类固醇; 抗凝治疗、出血性疾病; 放射治疗后4到6个月内使用; 已知或疑有恶性肿瘤、有癌症病史或任何类型的恶性肿瘤; 深静脉血栓形成; 眼眶或生殖器部位：在眼眶或生殖器部位使用; 治疗区域：治疗区域出血; 起搏器; 甲状腺或其他内分泌腺：在甲状腺或其他内分泌腺上使用
Composition不适用N/A
Storage运输及储存条件：环境温度 -10°C 至 +55°C; 运输及储存条件：仅在原容器中运输; 运输及储存条件：环境压力 650 hPa 至 1100 hPa; 运输及储存条件：相对湿度 10% 至 85%，无凝结
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可能的副作用：暂时性的低敏感性; 可能的副作用：因热而产生不适感; 可能的副作用：刺痛感; 可能的副作用：红斑; 可能的副作用：暂时性的高敏感性
Warnings新生儿、婴儿、儿童：不建议在新生儿、婴儿和儿童中使用本产品; 头部：请勿对头部进行扫描系统治疗; 整个治疗过程中必须对患者进行疼痛或不适感监测；如果患者不耐受治疗，请立即停止治疗; 所有在手术现场的人员皆需配戴护目镜; 请勿隔着衣物治疗，只可在裸露的皮肤表面治疗; 整个治疗过程中必须保持握把移动，避免定点使用; 所有患者均应根据 Fitzpatrick 接受皮肤类型评估（详见原厂使用手册），必须根据此评估调整治疗参数; 本产品仅限经过专业训练与认证的医师使用；使用者应熟悉所有安全预防措施、操作程序和维护说明
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. 37 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20213090309 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注进20213090309 change

    官网变更：代理人住所由深圳市福田区福田街道福华一路98号卓越大厦705室; 变更为：深圳市福田区莲花街道福新社区益田路6009号新世界商务中心2903A、2904、2905B

  3. CN

    国械注进20213090309 change

    官网变更：载明的生产地址由：“30 Pastskoshosh shose, 4002 Plovdiv, Bulgaria，保加利亚普罗夫迪夫市4002帕斯特斯科肖诗大道30号”变更为：“载明的生产地址变更为:3 Vladaya, 4006 Plovdiv, Bulgaria, 保…

  4. CN

    国械注进20213090309 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20213090309: 官网变更：载明的生产地址由：“30 Pastskoshosh shose, 4002 Plovdiv, Bulgaria，保加利亚普罗夫迪夫市4002帕斯特斯科…2025-09-12
  • 国械注进20213090309: 官网变更：代理人住所由深圳市福田区福田街道福华一路98号卓越大厦705室; 变更为：深圳市福田区莲花街道福新社区益田路6009号新世界商务中心2903A、290…2025-06-09
  • 国械注进20213090309: certificate issued2021-08-06

Sources

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