Mozarc Medical US LLC

• Health Products Regulatory Authority, Medical Devices Department
  IrlandeContacter l’autorité →

Dispositifs placés dans 18 pays

• Pays-Bas41
• Autriche13
• Allemagne13
• Espagne13
• Finlande13
• France13
• Grèce13
• Irlande13
• Italie13
• Pologne13
• Belgique11
• Portugal11
• Tchéquie9
• Danemark7
• Norvège7
• Suède7
• Croatie3
• Bulgarie1

4 contacts identifiés

• KS
  PCVRR
• MC
  PCVRR
• KERSTEN Seth
  1. Ensuring 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. 2. Ensuring the post-market surveillance obligations in accordance with EU MDR Article 10 (10) are complied with in accordance with regulatory requirements. 3. Ensuring the reporting obligations for Vigilance and Field Safety Corrective Action Reporting per EU MDR Articles 87 to 91 are fulfilled.
  Masqué
• MING Carol
  1. Ensuring the technical documentation and the EU Declaration of Conformity are drawn up and kept up to date. 2. Ensuring that the statement in accordance with EU MDR Annex XV Chapter II Section 4.1 is issued for investigational devices.
  Masqué

• TÜV SÜD Product Service GmbH — 1 certificat — Mozarc Medical US LLC
• Mozarc Medical Ireland Ltd. — représente — Mozarc Medical US LLC
• KERSTEN Seth — Mozarc Medical US LLC
• MING Carol — Mozarc Medical US LLC