DentalMaster(Xiamen) Medical Technology Co., Ltd.

• Ministerie van Volksgezondheid, Welzijn en Sport
  NetherlandsContact the authority →

Devices placed in 6 countries

• Spain376
• France92
• Italy91
• Germany50
• Greece50
• Slovakia50

5 contacts identified

• LQ
  LIN Qianying

  PRRC
  View profile →
• LIU Yuangang
  In accordance with the European Union Medical Device Regulation (EU) 2017/745 (MDR), ensure the quality management system is in compliance in the most effective manner and in a manner that is proportionate to the risk class and the type of device.
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• LI Junfeng
  1.Ensure technical documentation and the EU Declaration of Conformity are prepared and maintained per EU MDR 2017/745. 2.Ensure post-market surveillance (PMS) obligations are fulfilled and the PMS system is implemented and maintained per EU MDR 2017/745 and the PMS Control Procedure. 3.Ensure a signed statement confirms the investigational device conforms to general safety and performance requirements and all precautions for subject health and safety are taken, per EU MDR 2017/745.
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• CHEN Yubin
  In accordance with the European Union Medical Device Regulation (EU) 2017/745 (MDR), ensure that the vigilance reporting obligations are fulfilled in compliance with Articles 87 to 91 of the European Union Medical Device Regulation (EU) 2017/745 (MDR), and Control Procedure of the European Vigilance System.
  Hidden
• QIU Meifang
  In accordance with the European Union Medical Device Regulation (EU) 2017/745 (MDR), ensure the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
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No certificates registered for this manufacturer.

• Lotus NL B.V. — represents — DentalMaster(Xiamen) Medical Technology Co., Ltd.
• LIN Qianying — DentalMaster(Xiamen) Medical Technology Co., Ltd.