groupe lépine

• Agence Nationale de Sécurité du Médicament et des Produits de Santé
  FranceContact the authority →

Devices placed in 22 countries

• France2109
• Italy314
• Spain242
• Germany241
• Poland220
• Cyprus218
• Denmark212
• Bulgaria211
• Belgium201
• Lithuania193
• Ireland181
• Austria176
• Portugal176
• Romania174
• Estonia172
• Netherlands172
• Sweden169
• Slovenia169
• Greece9
• XI2
• Finland1
• Luxembourg1

No certificates registered for this manufacturer.

6 contacts identified

• FL
  FISCUS Laurence

  PRRC
  View profile →
• GM
  GENEVOIS Marion

  PRRC
  View profile →
• SO
  SABRE Olivier

  PRRC
  View profile →
• FISCUS Laurence
  - the conformity of all Groupe Lépine medical devices, and associated QMS - product release - manufacture - the technical documentation and the EU declaration of conformity - the post-market surveillance obligations - the reporting obligations (more details on Article 15 of the Medical Device Regulation)
  Hidden
• SABRE Olivier
  PRRC DEPUTY for : - the conformity of the devices is properly verified, in accordance with the quality management system under which the devices concerned are manufactured, before a device is released; - the notification obligations referred to in Articles 87 to 91 are fulfilled; - in the case of devices under investigation, the declaration referred to in Annex XV, Chapter II, Section 4.1 is issued.
  Hidden
• GENEVOIS Marion
  PRRC DEPUTY FOR : - technical documentation and the EU declaration of conformity are drawn up and kept up to date; - post-marketing surveillance obligations are fulfilled, in accordance with Article 10, paragraph 10;
  Hidden

• groupe lépine — FR-IM-000034872
• groupe lépine — FR-MF-000001182
• groupe lépine — FR-PR-000034873 · inactive
• FISCUS Laurence — groupe lépine
• GENEVOIS Marion — groupe lépine
• SABRE Olivier — groupe lépine