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【客户风采】武汉戴美“半导体激光治疗仪”获批上市!

  • 2026-09-02 19:15:33
【客户风采】武汉戴美“半导体激光治疗仪”获批上市!

致众检测（湖北）有限公司作为湖北首家同时具备国家认证认可监督管理委员会检验检测机构资质认定证书（CMA）GB 9706.1-2020、YY 9706.102-2021新版标准和中国合格评定国家认可委员会实验室认可证书（CNAS）的第三方医疗器械检验检测机构，严格按照ISO 17025、CNAS-CL01标准要求建立，体系管理水平和检测技术能力均达到国家认可水平，已建有电磁兼容、安规、环境及可靠性、微生物检测、包装验证等五大功能医疗器械检验实验室，可为各类医疗器械产品提供注册检验、研发验证等优质服务，全力为医疗器械企业的研发和生产保驾护航！

2026年6月2日，由武汉戴美激光科技有限公司研发生产的Ⅲ类医疗器械——"半导体激光治疗仪"正式获批上市！（注册证编号：国械注准20263091155）

此产品由主机和手柄组件两部分组成，主机包括半导体激光器、散热装置、激光电源系统、微机控制系统和辐射防护装置；手柄组件包括医用激光光纤，电缆和理疗手柄。用于暂时缓解由于膝关节骨关节炎引起的疼痛，促进肌肉组织放松，短时间改善局部血液循环。

致众全力护航

作为本项目的医疗器械检测检验服务提供方，致众检测为戴美激光"半导体激光治疗仪"提供了全面的检测检验服务，助力客户高效完成注册审批，顺利取得上市资格。致众检测将持续以专业、高效的检测检验能力，陪伴更多医疗器械企业走向合规上市之路。

GB 7247.1系列标准主要覆盖各类激光产品及其安全要求，如：激光手术刀、激光治疗仪、激光美容仪、眼科激光治疗设备等激光医疗设备，激光脱毛仪、激光祛斑设备等激光美容设备等。致众检测拥有GB/T 7247.1-2024、GB 9706.222-2022、YY 0307-2022、GB/T 12257-2023、YY 0789-2024、YY 0845-2011、YY 1289-2022、YY/T 0758-2021、YY/T 1751-2020系列等激光产品安全标准的项目检测能力，致力于为激光医疗器械产品质量安全筑牢防线！

关于致众检测

致众检测使用面积约2500平方米，坐落于武汉软件新城，是致众科技集团照国际标准ISO 17025要求、CNAS-CL01准则建⽴的综合性医疗器械检验机构，旨在建设具有国内先进技术水平和优质服务的医疗器械检验及研发实验室。研究院一期工程建立了电磁兼容、安规、环境及可靠性、微生物检测、包装验证等五大功能实验室，可提供完整优质的委托检测与技术培训服务。

近期活动
【合肥】第19期“有源医疗器械法规公益培训班”
【成都】国际医疗器械法规公益培训班
【深圳】《GB/T 42125.1-2024测量、控制和实验室用电气设备的安全要求 第1部分:通用要求》新标解读
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