进行医疗认证服务的唯一可靠途径

UL 能够为你提供符合你要求的整合性服务方案:

  • 欧洲 MDD和 IVDD
  • 美国食品和药品管理局(FDA)
  • 加拿大治疗性产品计划/CMDCAS
  • 日本健康和保障部(MHW)
  • 全世界 CB 方案和第三方检测

请查阅UL 510(k)审核服务的详情

欧洲医疗设备规范

在欧洲销售的所有医疗设备(有源的,无源的和消毒的设备)都必须遵守医疗设备规范 (MDD) 93/42/EEC 的规定,且每台设备必须带有CE(欧洲标准)标志。UL提供证明机构服务,可授权客户在产品的CE标志旁同时粘贴证明机构号。

美国食品和药品管理局的第三方计划

UL是属于美国食品和药品管理局第三方计划中的认证机构,在全球拥有510(k)专家,不断推动认证活动,助你早日将产品投放市场。

加拿大Canada – Therapeutic Products Programme/CMDCAS

治疗性产品计划/CMDCAS UL是经加拿大标准协会(SCC)认可的,按加拿大医疗设备合格性评估系统(CMDCAS)对各个公司的合格性进行认证和注册的结构。

Debug section - only for DEV!

$gdpralert

GdprAlert Object
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$GLOBALS["wp_actions"]

Array
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$_SERVER

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