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半导体激光脱毛仪Magma国械注进20223090351

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半导体激光脱毛仪Magma is a Energy-based device product (Class III device), registered by Formatk Systems Ltd.. Linked registrations: China 国械注进20223090351. Data as of 2026-10-23.

  • Regulatory classEnergy-based device · Class III device
  • HolderFormatk Systems Ltd.
  • JurisdictionsCN · TW
  • Updated2026-10-23 · v1

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

Registration and basics

半导体激光脱毛仪Magma

Product
Regulatory class
Class III device
Category
Energy-based device
China · NMPA device registration
国械注进20223090351
Registrant
以色列弗美迪克公司Formatk Systems Ltd.
China agent
欧华美科 (天津) 医学科技有限公司
First approval
Not obtained from an official source
This certificate issued
2022-07-15
Valid until
2027-07-14
Models and sizes
Magma
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非侵入式皮肤治疗：色素病变; 非侵入式皮肤治疗：血管病变; 非侵入式皮肤治疗：腿部静脉; 非侵入式皮肤治疗：痤疮; 非侵入式皮肤治疗：除毛
Contraindications禁忌症：怀孕; 禁忌症：治疗部位有发炎或感染症状; 禁忌症：接受过抗凝治疗; 禁忌症：治疗部位有纹身或永久性化妆; 禁忌症：患有疱疹性疾病; 禁忌症：具有癌症病史; 禁忌症：药物引起的光敏反应; 禁忌症：患有严重糖尿病; 禁忌症：患有盘状红斑狼疮; 禁忌症：患有自体免疫性疾病
Composition不适用N/A
Storage储存/运输：储存/运输压力 500-1060 HPA; 储存/运输：储存/运输温度 5ºC - 55ºC; 储存/运输：储存/运输相对湿度最高80%，未凝结
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脉冲或雷射治疗：可能并发症：色素沉着过多/过少; Fitzpatrick V-IV：皮肤类型为 V-IV（根据 Fitzpatrick 量表）的患者可能出现延迟反应，应进行相应测试; 脉冲或雷射治疗：可能并发症：红斑（皮肤发红）; 脉冲或雷射治疗：可能并发症：不适感; 脉冲或雷射治疗：可能并发症：疤痕; 脉冲或雷射治疗：可能并发症：水肿（肿胀）
Warnings如果患者具有任何原厂使用说明书所载的禁忌症，请勿对该患者使用本产品进行任何治疗。; 切勿直视探头发出的光，即使已配戴安全防护眼镜也不得直视。; 本产品内部有高电压；未移除系统电源时，请勿尝试任何涉及内部零件的维护程序。; 只有经过培训的合格人员才能操作本产品。; 为避免触电危险，本产品必须连接到具有接地保护的主电源。; 告知患者治疗方案、可能的结果以及与治疗相关的任何风险。; 注意：若使用原厂使用说明书所载以外的操控、调整或执行步骤，可能导致辐射暴露风险。; 为避免火灾和/或爆炸风险，请勿在存有易燃材料、溶液或气体或在富氧环境中操作雷射设备。
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. 39 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20223090351 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注进20223090351 change

    官网变更：注册人名称由：以色列美迪迈医疗科技公司 ;变更为：以色列弗美迪克公司

  3. CN

    国械注进20223090351 change

    注册人名称由：以色列美迪迈医疗科技公司 ;变更为：以色列弗美迪克公司

  4. CN

    国械注进20223090351 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20223090351: 官网变更：注册人名称由：以色列美迪迈医疗科技公司 ;变更为：以色列弗美迪克公司2024-06-03
  • 国械注进20223090351: 注册人名称由：以色列美迪迈医疗科技公司 ;变更为：以色列弗美迪克公司2024-06-03
  • 国械注进20223090351: certificate issued2022-07-15

Sources

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