大同CE认证

上海峦灵将为您提供如下欧盟授权代表服务
产品于欧盟注册
非欧盟国家的制造商或出口商，其产品允许在欧盟市场销售前，应委任欧盟授权代表。只有当产品满足欧盟相关法规或指令要求，并且在产品或包装上标明授权代表的名称和，才允许在欧盟自由销售或使用。

Minimum requirements
Verify the Declaration of Conformity
Review the Technical Documentation
Check where applicable that an appropriate conformity assessment exist
Keep the previous documentation (Declaration of conformity, Technical Documentation, certificates issued by Notified Body and amendments) at
the disposal of competent authorities (at least 10 years and for implantable devices it's 15 years)
Verify that the manufacturer is complying with the registration of the
Unique Device Identification according to article 27

Minimum requirements：
Make sure that the registration of the device is performed according to
article 29
Also that the registration of the manufacturer, Authorized Representative and importers are done according to article 31
In case requested by the competent authorities, the Authorized Representative should give all the information and documentation necessary to prove the conformity of a device, in an official language
Keep the manufacturer informed of any request coming from the
competent authorities.
Verify that the competent authorities receives the samples or is given access to the device

? Located outside EU
Companies outside EU can be out of EU law as they have no place of business there.
? Want to sell Medical Devices To receive authorization to sell your Medical Devices in EU you have to
appoint one. It will be mandatory to get your CE certification from the Notified Body.
关于我们：峦灵是行业内**的咨询公司，汇聚了来自法规、等各领域对法规有深刻理解的人士及*，致力为企业提供一站式、*、系统化的技术咨询服务。迄今为止，我们已与众多公司开展合作, 协助他们将安全、有效、合规的产品迅速推向**市场。

峦灵是行业内的咨询公司，汇聚了来自法规、等各领域对法规有深刻理解的人士及*，致力为企业提供一站式、*、系统化的技术咨询服务， 帮助企业向**市场提供安全、有效和合规的产品， 迄今为止，我们已与众多公司开展合作, 协助他们将安全、有效、合规的产品迅速推向**市场。 我们的服务包括： 法规合规服务（CE认证、NMPA注册、FDA注册、**注册） 质量管理体系（ISO13485、NMPA GMP、MDSAP、FDA QSR820、质量体系日常维护服务）； 测试服务（有源产品测试认证咨询、无源产品测试认证咨询、清洗消毒灭菌验证确认、定制化摸底测试服务） **注册（加拿大、澳大利亚、日本、巴西、韩国、俄罗斯、东南亚注等）； 法规培训服务（企业定制培训、小班课培训）