Shanghai MicroPort EP MedTech Co., Ltd.

• Ministerie van Volksgezondheid, Welzijn en Sport
  Pays-BasContacter l’autorité →

Dispositifs placés dans 17 pays

• France48
• Bulgarie47
• Allemagne41
• Portugal41
• Espagne39
• Grèce34
• Italie22
• Turquie22
• Pays-Bas16
• Pologne15
• Roumanie14
• Slovaquie2
• Danemark1
• Finlande1
• Hongrie1
• Lituanie1
• Lettonie1

4 contacts identifiés

• GB
  GAO Bin

  PCVRR
  Voir le profil →
• SY
  SONG Yuwen

  PCVRR
  Voir le profil →
• GAO Bin
  1) Ensure to establish, record, implement and maintain the updated and continuously improving quality management system. Before the release, ensure the conformity of the devices is appropriately checked. 2) Ensure the post-market surveillance (PMS) activities compliance with Article 10 (10) in MDR, and ensure the implementation of PMS activities and keep up-to-date. 3) Perform the duties including reporting obligation referred to in Article 87, Article 88, Article 89 and Article 90 in MDR.
  Masqué
• SONG Yuwen
  1) Ensure the technical documentation and EU declaration of conformity are drawn up and kept up-to-date. 2) For investigational devices, give a statement referred to in Section 4.1 of Chapter II of Annex XV. It should be stated that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.
  Masqué

• UDEM Adriatic d.o.o. — 1 certificat — Shanghai MicroPort EP MedTech Co., Ltd.
• MicroPort Medical B.V. — représente — Shanghai MicroPort EP MedTech Co., Ltd.
• GAO Bin — Shanghai MicroPort EP MedTech Co., Ltd.
• SONG Yuwen — Shanghai MicroPort EP MedTech Co., Ltd.