Endo Tools Therapeutics S.A

• Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
  BelgiumContact the authority →

6 contacts identified

• HF
  HERALY Fréderic

  PRRC
  View profile →
• NN
  NABET Natacha

  PRRC
  View profile →
• RM
  ROUYER Marine

  PRRC
  View profile →
• ROUYER Marine
  Ensuring conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released. Ensuring technical documentation and the EU declaration of conformity are drawn up and kept up to date. Ensuring PMS obligations are complied with in accordance with EU MDR Article 10(10). Ensuring reporting obligations referred to in EU MDR Articles 87 to 91 are fulfilled. Issuing a signed statement for investigational devices (Annex XV)
  Hidden
• NABET Natacha
  PRRC delegate, same responsibilities as the PRRC.
  Hidden
• HERALY Fréderic
  Ensuring conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released. Ensuring technical documentation and the EU declaration of conformity are drawn up and kept up to date. Ensuring PMS obligations are complied with in accordance with EU MDR Article 10(10). Ensuring reporting obligations referred to in EU MDR Articles 87 to 91 are fulfilled. Issuing a signed statement for investigational devices (Annex XV)
  Hidden

Devices placed in 31 countries

• Austria1
• Belgium1
• Bulgaria1
• Cyprus1
• Czechia1
• Germany1
• Denmark1
• Estonia1
• Spain1
• Finland1
• France1
• Greece1
• Croatia1
• Hungary1
• Ireland1
• Italy1
• Liechtenstein1
• Lithuania1
• Luxembourg1
• Latvia1
• Malta1
• Netherlands1
• Norway1
• Poland1
• Portugal1
• Romania1
• Sweden1
• Slovenia1
• Slovakia1
• Türkiye1
• XI1

• BSI Group The Netherlands B.V. — 1 certificate — ETT
• HERALY Fréderic — ETT
• NABET Natacha — ETT
• ROUYER Marine — ETT